Method, system and apparatus for using electromagnetic radiation for monitoring a tissue of a user

ABSTRACT

A wearable monitoring apparatus for monitoring at least one biological parameter of an internal tissue of an ambulatory user. Said wearable monitoring apparatus comprises at least one transducer configured for delivering electromagnetic (EM) radiation to said internal tissue and intercepting a reflection of said EM radiation said reform in a plurality of transmission sessions during at least 24 hours, a processing unit configured for analyzing respective said reflection and identifying a change in said at least one biological parameter accordingly, a reporting unit configured for generating a report according to said change, and a housing for containing said at least one transducer, said reporting unit, and said processing unit, said housing being configured for being disposed on said body of said ambulatory user.

RELATED APPLICATION

This application is co filed with a patent application by Dan RAPPAPORT,Nadav MIZRAHI, Shlomi BERGIDA, Amir SAROKA, Amir RONEN, and Ilan KOCHBA,entitled method and system for monitoring thoracic fluids, which thecontent thereof is incorporated by reference as if fully set forthherein.

FIELD AND BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates tomonitoring and, more particularly, but not exclusively, to using EMradiation for monitoring changes of an internal biological tissue.

Medical instruments in which an echo of a pulse of EM radiation is usedto detect and locate structures in the human body are known, see YOUNG,J. D et. al. Examination of video pulse radar systems as potentialbiological exploratory tools in LARSEN, L. E., and JACOBI, J. H. (Eds.):‘Medical applications of microwave imaging’ (IEEE Press, New York,1986), pp. 82-105, which is incorporated herein by reference. Suchmedical instruments includes microwave imaging devices, which may bereferred to as tissue sensing adaptive radar (TSAR) or Imaging and othermedical devices for detecting and possibly imaging internal biologicaltissues. The use of electromagnetic waves eliminates the need to exposethe tissues to ionizing radiation, as performed during X-ray imaging,and to obtain relatively large tissue contrasts according to their watercontent.

One of the most common antennas which are used for such medicalinstruments is the well known biconic bow-tie antenna that maintains itsport impedance and radiation pattern act in frequencies between certainlimits where the low frequency is dictated by the size of the length ofthe cones and the upper limit by the port capacitance and feedingconstruction, see Antenna Theory, C. A. Balanis, 2 ed. John Willey, 1997which is incorporated herein by reference. Such antennas usually sufferfrom a poor performance at relative low frequencies, where bodyelectromagnetic penetration is better, and a planar construction thatmay be damaged due to electro-static discharges (ESD).

Such antennas have been used for detecting and imaging variouspathologies, such as breast cancer. For example, U.S. Pat. No. 6,061,589issued on May 20, 2000 describes a microwave antenna for use in a systemfor detecting an incipient tumor in living tissue such as that of ahuman breast in accordance with differences in relative dielectriccharacteristics. In the system a generator produces a non-ionizingelectromagnetic input wave of preselected frequency, usually exceedingthree gigahertz, and that input wave is used to irradiate a discretevolume in the living tissue with a non-ionizing electromagnetic wave.The illumination location is shifted in a predetermined scanningpattern. Scattered signal returns from the living tissue are collectedand processed to segregate skin tissue scatter and to develop asegregated backscatter or return wave signal; that segregated signal, inturn, is employed to detect any anomaly indicative of the presence of atumor or other abnormality in the scanned living tissue. The presentinvention is directed to a composite Maltese Cross or bow-tie antennaconstruction employed to irradiate the living tissue and to collectbackscatter or other scatter returns.

In another example, U.S. Pat. No. 6,919,838 published on Jul. 19, 2005,describes a scanner or imager that employs a plurality of microwavetransmitters that emit a multiplicity of pulses, which are received by aplurality of receivers. An object or person positioned between thetransmitters and receivers can be scanned and subsequently imaged inextreme detail, due to the broad spectral content of the pulses. Thescanner can be constructed as a stationary or portable device.

SUMMARY OF THE INVENTION

According to an aspect of some embodiments of the present inventionthere is provided a wearable monitoring apparatus for monitoring atleast one biological parameter of an internal tissue of an ambulatoryuser. The wearable monitoring apparatus comprises at least onetransducer configured for delivering electromagnetic (EM) radiation tothe internal tissue and intercepting at least one reflection of the EMradiation therefrom in a plurality of transmission sessions during aperiod of at least 24 hours, a processing unit configured for analyzingthe at least one reflection and identifying a change in the at least onebiological parameter accordingly, a reporting unit configured forgenerating a report according to the change, and a housing forcontaining the at least one transducer, the reporting unit, and theprocessing unit, the housing being configured for being disposed on thebody of the ambulatory user.

Optionally, the processing unit comprises a communication module forcommunicating with a remote processing unit thereby allowing performingof at least one of the analyzing and the identifying by the remoteprocessing unit.

Optionally, the processing unit is configured for identifying the changeby detecting at least one of a trend, a biological process, and apattern according to the at least one reflection of the plurality oftransmission sessions.

Optionally, the processing unit is configured for evaluating a change ina dielectric related property of the internal tissue in at least one ofthe plurality of transmission sessions and performing the identificationaccording to the dielectric related property.

Optionally, the plurality of transmission sessions are performed in anadaptive rate.

More optionally, the adaptive rate is determined according to a clinicalstate of the user, the processing unit being configured for calculatingthe clinical state according to at least one output of a biologicalsensor and the at least one reflection.

Optionally, the wearable monitoring apparatus further comprises aposture detection unit configured detecting a posture of the user, theadaptive rate being determined according to the posture.

Optionally, the reporting unit configured for generating the report inreal time.

Optionally, the reporting unit is configured for presenting the reportto the ambulatory user.

Optionally, the change is indicative of a fluid content change in theinternal tissue during the period.

Optionally, the change is indicative of a member of a group consistingof: a trauma a degenerative process, atelectasis, a post-operativeatelectasis, an acute respiratory deficiency syndrome (ARDS), aninfectious cause, an inhaled toxins, a circulating exogenous toxins, avasoactive substance, a disseminated intravascular coagulopathy (DIC), aburn, an emphysema, a immunologic processes reaction, a uremia, a postdrowning lung water level, a pulmonary venous thrombosis, a stenosis, aveno-occlusive disease, a hypoalbuminemia, a lymphatic insufficiency, ahigh altitude pulmonary edema (HAPE), a neurogenic pulmonary edema, adrug overdose, a pulmonary embolism, an eclampsia, a postcardioversion,a postanesthetic, a postextubation, and a post-cardiopulmonary bypass aninflammation progress of ARDS users, postoperative atelectasis.

Optionally, the housing is configured for being disposed on the body ofthe ambulatory user during a physical exertion thereof, the change beingindicative of a fluid content change resulting from the physicalexertion.

Optionally, the wearable monitoring apparatus further comprises arepository configured for storing information pertaining to the user,the processing unit being configured for performing the analyzing withrespect to the information, wherein the information comprises at leastone of physiological, anatomical, and clinical data related to the user.

Optionally, the wearable monitoring apparatus further comprises a non EMradiation sensor configured for evaluating an indicator of the physicalcondition of the user, the processing unit being configured forperforming the analyzing with respect to the evaluated indicator.

More optionally, the processing unit is configured for identifying thechange by a combination of the indicator and the at least one reflectionof the plurality of transmission sessions.

More optionally, the non EM radiation sensor is a member of a groupconsisting of electromyogram (EMG), an ultrasound transducer, a bloodpressure sensor, an optical blood saturation detector, a pulse oximeter,electrocardiogram (ECG), tiltmeter and accelerometer an activity sensor,and a coagulometer.

Optionally, the wearable monitoring apparatus further comprises abiological sensor configured detecting a pattern of a vitalphysiological activity of the user, the processing unit being configuredfor performing the analyzing with respect to the pattern.

More optionally, the pattern is a member of a group consisting of: aheart beat rate, breathing cycle, systole diastole cardiac cycle, and ablood cycle effect on the internal tissue.

Optionally, the processing unit is configured for detecting a pattern ofa vital physiological activity of the user by analyzing the at least onereflection, the processing unit being configured for performing theanalyzing with respect to the pattern.

More optionally, the pattern is a member of a group consisting of: asystole diastole cardiac cycle and a breathing cycle.

Optionally, the processing unit is configured for detecting a vitalphysiological activity of the user by analyzing the at least onereflection, the processing unit being configured for performing theidentifying with respect to the vital physiological activity.

Optionally, the wearable monitoring apparatus further comprises aposture detection unit configured detecting a posture of the user, theprocessing unit being configured for analyzing the at least onereflection with respect to the posture.

Optionally, the change is indicative of a change in the concentration ofa solute in the internal tissue.

More optionally, the solute is a member of a group consisting of a salt,glucose, and or inflammatory indicative fluid.

Optionally, the reporting unit is configured for transmitting the reportto a management center.

Optionally, the EM radiation comprises a narrowband signal of less than50 Mega Hertz (MHz) bandwidth and a pulse signal of at least 0.5gigahertz (GHz) bandwidth.

Optionally, the EM radiation is transmitted in a swept frequency mode.

Optionally, the EM radiation is transmitted in a plurality offrequencies.

Optionally, the wearable monitoring apparatus further comprises aplacement unit for providing a position of the at least one transducerin relation to a reference internal tissue of the user, the deliveringbeing performed with respect to the position.

Optionally, the wearable monitoring apparatus further comprises aplacement unit configured for receiving a positioning data indicative ofa historical position of at least one of a similar wearable monitoringapparatus and the wearable monitoring apparatus in relation to at leastone reference internal tissue, the placement unit being configured forusing the historical position as a reference for positioning thewearable monitoring apparatus.

Optionally, the at least one transducer comprises a planar wide bandantenna.

Optionally, the at least one transducer is positioned in proximity tothe skin of the ambulatory user.

Optionally, the housing is configured to be integrated into a garment.

Optionally, the reporting unit is configured for forwarding the reportto a dosage control unit, the dosage control unit being configured forat least one of dispensing of a medication according to the report andpresenting a dosage recommendation according to the report.

More optionally, the housing containing the dosage control unit.

More optionally, the dispensing is related to an oncology treatment.

Optionally, the processing unit is configured for identifying the changeusing a tissue model adapted to the internal tissue.

Optionally, the at least one transducer comprises a plurality oftransducers configured for delivering EM radiation to the internaltissue and intercepting the at least one reflection therefrom.

More optionally, the plurality of transducers comprises at least onetransmitter configured for performing the delivering and at least onereceiver configured for performing the intercepting.

More optionally, the at least one transducer being configured forintercepting the at least one reflection from a plurality of sub-areasof the internal tissue for improving the resolution of the at least onereflection.

More optionally, the processing unit is configured for reducing at leastone of a noise, a disturbance, a posture movement effect and/or aninterference intercepted by the at least one first transducer bycomparing portions of the at least one reflection from the first andsecond sub-areas.

According to an aspect of some embodiments of the present inventionthere is provided a system for monitoring at least one biologicalparameter of an internal tissue of a plurality of ambulatory users. Thesystem comprises a plurality of wearable devices, each configured forbeing disposed on the body of one of the plurality of ambulatory usersand for identifying a change in the at least one biological parameteraccording to at least one reflection of electromagnetic (EM) radiationfrom an internal tissue of a respective of the ambulatory users and auser management unit configured for receiving the identified change froma respective the wearable device and generating a report accordingly.

Optionally, the user management unit is configured for alerting acaretaker by forwarding the report to a remote client terminalassociated with the caretaker.

Optionally, the remote client terminal is a member of a group consistingof a cellular phone, a computer, a medical data center, medical datasystem, and a medical database

Optionally, the user management unit is configured for updating at leastone of the plurality of wearable devices with medical data related to arespective of the plurality of ambulatory users.

Optionally, the user management unit is configured for prioritizing atreatment to at least some of the plurality of ambulatory usersaccording to respective the identified change.

Optionally, the user management unit is configured for receiving atechnical status indication from each the wearable device.

Optionally, the user management unit is configured for forwarding atleast one of the report and the identified change to allow updating of amedical data system.

According to an aspect of some embodiments of the present inventionthere is provided a wearable monitoring apparatus for identifying aposture of a user. The wearable monitoring apparatus comprises at leastone transducer configured for delivering electromagnetic (EM) radiationto an internal tissue and intercepting a reflection of the EM radiationtherefrom, a processing unit configured for analyzing the reflection andidentifying a posture of the user accordingly, and an output unitconfigured for generating an indication of the posture.

Optionally the apparatus further comprises a housing for containing theat least one transducer, the processing unit and the output unit, thehousing being configured for being disposed on the body of the user.

More optionally, the housing comprises a biological probe.

Optionally, the output unit is configured for presenting at least onemovement instruction to execute a predefined posture according to theposture.

Optionally, the apparatus further comprises a sensor for detecting abiological parameter, the processing unit configured for performing theidentifying with respect to the biological parameter.

According to an aspect of some embodiments of the present inventionthere is provided a wearable monitoring apparatus for detecting aposture of a user. The wearable monitoring apparatus comprises at leastone transducer configured for delivering electromagnetic (EM) radiationto an internal tissue and intercepting a reflection of the EM radiationtherefrom, a processing unit configured for analyzing the reflection andidentifying a positioning of the internal tissue in relation to the EMradiation accordingly, and an output unit configured for generating anindication of the positioning.

According to an aspect of some embodiments of the present inventionthere is provided a method for detecting a body posture. The methodcomprises delivering electromagnetic (EM) radiation to an internaltissue of a user, intercepting a reflection of the EM radiationtherefrom, and identifying a change in the posture of the user accordingto the reflection.

Optionally, the EM radiation comprises a narrowband signal of less than50 Mega Hertz (MHz) bandwidth and a pulse signal of at least 0.5gigahertz (GHz) bandwidth.

According to an aspect of some embodiments of the present inventionthere is provided an apparatus for detecting a misplacement of abiological probe in relation to an internal tissue of a user. Theapparatus comprises a repository configured for storing at least onereference value indicative of an at least one exemplary reflection ofelectromagnetic (EM) radiation delivered to an internal tissue of theuser, at least one transducer configured for delivering, the EMradiation to the internal tissue and intercepting at least one actualreflection of the EM radiation therefrom, and a processing unitconfigured for identifying the misplacement by comparing between the atleast one reference value and an actual value calculated according tothe intercepting at least one actual reflection.

Optionally, the EM radiation comprises a narrowband signal of less than50 Mega Hertz (MHz) bandwidth and a pulse signal of at least 0.5gigahertz (GHz) bandwidth.

Optionally, the at least one reference value is a range of values.

Optionally, the apparatus further comprises an output unit configuredfor forwarding an indication pertaining to the misplacement to a remotesystem via a communication network.

Optionally, the apparatus further comprises a guiding unit configuredfor presenting at least one repositioning instruction directing at leastone of the user and a caretaker to reposition the biological probeaccording to the identified misplacement.

Optionally, the apparatus further comprises a mechanical adjustment unitfor automatically changing the position of the biological probeaccording to the identified misplacement.

Optionally, the apparatus further comprises a communication interfaceconfigured for notifying a management node about the misplacement.

More optionally, the management node is configured for changing abilling data pertaining to user according to the indication.

Optionally, the biological probe is a wearable element.

According to an aspect of some embodiments of the present inventionthere is provided a method configured for detecting a misplacement of abiological probe in relation to an internal tissue of a user. The methodcomprises providing at least one reference value indicative of an atleast one exemplary reflection of electromagnetic (EM) radiationdelivered to an internal tissue of a user wearing the biological probe,delivering the electromagnetic (EM) radiation to the internal tissue,intercepting a at least one actual reflection of the EM radiationtherefrom, and identifying the misplacement by comparing between the aactual value calculated according at least one actual reflection and theat least one reference value.

Optionally, the method further comprises presenting a set ofinstructions for instructing the placement of the biological probeaccording to the misplacement.

Optionally, the EM radiation comprises a narrowband signal of less than50 Mega Hertz (MHz) bandwidth and a pulse signal of at least 0.5gigahertz (GHz) bandwidth.

Optionally, the method further comprises receiving positioning datarelated to a previous positioning of the biological probe, themisplacement identified in relation to the positioning data.

According to an aspect of some embodiments of the present inventionthere is provided a wideband antenna. The wideband antenna comprises aprinted metallic field transducer for transmitting EM radiation and anarrangement of at least one lumped absorbing element. The arrangementhaving a minimal absorption area absorbing at least 75% of the energyabsorbed by the arrangement. The a first distance is the smallestdistance between a geometric center of the printed metallic fieldtransducer and a perimeter encircling a transmission area of the printedmetallic field transducer required for transmitting 50% of the energy ofthe EM radiation in the lowest end of a used frequency band with respectto infinite size transducer. The distance of each point within theminimal absorption area from the geometric center is at least the firstdistance.

Unless otherwise defined, all technical and/or scientific terms usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which the invention pertains. Although methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of embodiments of the invention, exemplarymethods and/or materials are described below. In case of conflict, thepatent specification, including definitions, will control. In addition,the materials, methods, and examples are illustrative only and are notintended to be necessarily limiting.

Implementation of the method and/or system of embodiments of theinvention can involve performing or completing selected tasks manually,automatically, or a combination thereof. Moreover, according to actualinstrumentation and equipment of embodiments of the method and/or systemof the invention, several selected tasks could be implemented byhardware, by software or by firmware or by a combination thereof usingan operating system.

For example, hardware for performing selected tasks according toembodiments of the invention could be implemented as a chip or acircuit. As software, selected tasks according to embodiments of theinvention could be implemented as a plurality of software instructionsbeing executed by a computer using any suitable operating system. In anexemplary embodiment of the invention, one or more tasks according toexemplary embodiments of method and/or system as described herein areperformed by a data processor, such as a computing platform forexecuting a plurality of instructions. Optionally, the data processorincludes a volatile memory for storing instructions and/or data and/or anon-volatile storage, for example, a magnetic hard-disk and/or removablemedia, for storing instructions and/or data. Optionally, a networkconnection is provided as well. A display and/or a monitored user inputdevice such as a keyboard or mouse are optionally provided as well.

BRIEF DESCRIPTION OF THE DRAWINGS

Some embodiments of the invention are herein described, by way ofexample only, with reference to the accompanying drawings. With specificreference now to the drawings in detail, it is stressed that theparticulars shown are by way of example and for purposes of illustrativediscussion of embodiments of the invention. In this regard, thedescription taken with the drawings makes apparent to those skilled inthe art how embodiments of the invention may be practiced.

In the drawings: FIG. 1 is a schematic illustration of a wearablemonitoring apparatus that is attached to the thorax of a user 101 andoptionally connected to a user management unit, according to someembodiments of the present invention;

FIG. 2 is a schematic illustration of an exemplary system for managingthe monitoring dielectric related properties of internal tissues of oneor more users, according to some embodiments of the present invention;

FIG. 3 is a schematic illustration of a set of components of anexemplary wearable monitoring apparatus, according to some embodimentsof the present invention;

FIG. 4A is a schematic illustration of an exemplary EM antenna of anexemplary EM transceiver, according to some embodiments of the presentinvention;

FIG. 4B is a schematic illustration of another exemplary EM antenna ofan exemplary EM transceiver, according to some embodiments of thepresent invention;

FIG. 4C is a lateral view of the exemplary EM antenna which is depictedin FIG. 4B, according to some embodiments of the present invention;

FIG. 5 is a schematic illustration of a right mid axillary line in whichthe wearable monitoring apparatus may be positioned, according to someembodiments of the present invention;

FIG. 6A, is a flowchart of a method for using EM radiation for detectinga posture of a user, according to some embodiments of the presentinvention;

FIG. 6B is a flowchart of a method for using EM radiation for detectingthe placement, misplacement and/or disengagement of a biological probe,according to some embodiments of the present invention; and

FIGS. 7 and 8 are schematic illustrations of a wearable monitoringapparatus with a plurality of transducers designed for beaming and/orcapturing EM waves, according to some embodiments of the presentinvention.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

The present invention, in some embodiments thereof, relates tomonitoring and, more particularly, but not exclusively, to using EMradiation for monitoring changes of an internal biological tissue.

According to some embodiments of the present invention, there isprovided a method and a wearable monitoring apparatus for monitoring oneor more biological parameters of an internal tissue of an ambulatoryuser. The apparatus is based on one or more transducers for deliveringelectromagnetic (EM) radiation to the internal tissue and intercepting areflection of the EM radiation therefrom in a plurality of transmissionsessions, which may be continuous or intermittent. The apparatuscomprises a processing unit that is used for evaluating the change offluid content of the internal tissue along the monitoring periodaccording to the reflections captured during the sessions andidentifying a change in the biological parameters accordingly. Theapparatus further comprises a reporting unit for generating a reportaccording to the change. The report may be forwarded to an MMI unit onthe wearable monitoring apparatus and/or to a remote management node,such as a medical center and/or a patient management unit.

The apparatus comprises a housing, which is optionally designed to beattached to the body of the patient without substantially changing hergeneral body contour, for containing the transducers, the reportingunit, and the processing unit. The housing is disposed on the body ofthe ambulatory user that is not confined to a certain location in whichmonitoring is conducted. Optionally, in order to reduce the air-skininterface and/or positioning change, the transducers are positionedconcomitantly to the body of the ambulatory user.

In some embodiments of the present invention, there is provided a systemfor monitoring biological parameters of an internal tissue of aplurality of ambulatory and/or hospitalized users. The system is basedon a plurality of wearable devices, each designed for being disposed onthe body of one of the plurality of ambulatory and/or hospitalized usersand for evaluating a change in a dielectric related property of aninternal tissue thereof. The system further comprises a user managementunit configured for receiving the evaluated changes from the wearabledevice and generating an alert accordingly, for example by displaying arespective indication to a caretaker. Such a system may be used tomonitor biological parameters of a plurality of ambulatory and/orhospitalized users, to gather statistics on these biological parameters,to prioritize treatment to the plurality of users and the like.

According to some embodiments of the present invention there is provideda method and an apparatus for detecting misplacement, placement, and ordisengagement of a biological probe, such as the wearable monitoringapparatus which is outlined above, in relation to an internal tissue ofa user. The apparatus comprises a memory element, which may be referredto herein as a repository, for storing reference values each indicativeof an exemplary reflection of EM radiation delivered to an internaltissue of the user from the biological probe and one or more transducersfor delivering, from the biological probe, the EM radiation to theinternal tissue and intercepting an actual reflection of the EMradiation therefrom. The apparatus further comprises a processing unitfor identifying the misplacement by comparing between the referencevalues and the actual reflection. Such an apparatus may be used forverifying patient compliance, alerting a user when the biological probeis misplaced, and/or for guiding a placing and/or a replacing of themedical biological probe.

According to some embodiments of the present invention there is provideda wearable monitoring apparatus for detecting a posture of a user. Thewearable monitoring apparatus may be integrated with the above mentionedapparatuses or with any medical biological probe which is used formonitoring a biological parameter of a patient and may be affected bythe posture thereof. The apparatus comprises one or more transducers fordelivering EM radiation to an internal tissue and intercepting areflection of the EM radiation therefrom and a processing unit forevaluating a dielectric related property of the internal tissue byanalyzing the reflection and identifying a posture of the user and/or achange of the posture of according to the intercepted reflections. Theapparatus further comprises an output unit configured for generating anindication of the posture and the change. Such an indication may be usedfor registration of related biological parameters, generating an alertand/or a report which is related to the physical condition of the user.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not necessarily limited in itsapplication to the details of construction and the arrangement of thecomponents and/or methods set forth in the following description and/orillustrated in the drawings and/or the Examples. The invention iscapable of other embodiments or of being practiced or carried out invarious ways.

Reference is now made to FIG. 1, which is a schematic illustration of awearable monitoring apparatus 100 that is attached to the body of auser, optionally to the thorax, as shown at 101. The wearable monitoringapparatus 100 is optionally connected to a user management unit 102,optionally in a bidirectional wireless connection, according to someembodiments of the present invention.

It should be noted that the wearable monitoring apparatus 100 and/or theuser management unit 102 may interface with and/or integrated todifferent systems of various medical centers, such as hospitals,caretaker clinics, long term care facilities, nursing homes, and homecare settings. As used herein a caretaker means a physician, a nurse, afamily member, an affiliate, a medical center staff member, a callcenter any entity which is in charged and/or should have access to themedical condition of the monitored user and/or a team of one or more ofthese caretakers.

The wearable monitoring apparatus 100 is designed for monitoring one ormore clinical parameters of an internal tissue and/or an organ bydetecting changes in the fluid content and/or composition, for exampleaccording to changes in the fluid content thereof, for example accordingto dielectric related properties that reflect changes in the amount offluids, such as water, blood, and/or inflammation fluids in themonitored internal tissue and/or organ, for example in the pulmonarytissues of the user 101 and/or in the area between the pericardium andthe heart and/or in the area between the visceral and parietal pleura.As used herein a dielectric related property of a specific volume meansthe magnetic permeability and electric permittivity of the compositematerial within a specific volume. Such a dielectric related propertymay be affected by a presence of fluid, a concentration of substances,such as salts, glucose, in the fluid in the internal tissue and/ororgan, the ratio of fibrotic tissue, and a concentration of inflammatorysubstance in the fluid in the internal tissue and/or organ.

In one example of the present invention, the wearable monitoringapparatus 100 is attached to the skull of a user and used for monitoringa build up of intra-cranial pressure which may be a consequence of ahead injury. In another of example of the present invention, thewearable monitoring apparatus 100 may be attached to the abdomen formonitoring abdominal bleeding, which may be a consequence of abdominalsurgery. In another example, the wearable monitoring apparatus 100 ispositioned on the lower abdomen for monitoring prostate relatedtreatments, such as irradiation and/or medication for carcinoma.

Optionally, the wearable monitoring apparatus 100 is designed to beattached to the thorax of a user 101, optionally as described below. Thewearable monitoring apparatus 100 may communicate, optionallywirelessly, with a user management unit 102, which may be connected tothe hospital IT unit, an emergency center and/or to a disease managementcenter.

Optionally, the wearable monitoring apparatus 100 comprises a thinhousing, optionally curved for allowing the attaching thereof to thebody of the user 101 without substantially changing her general bodycontour, for example as described below. Optionally, the wearablemonitoring apparatus 100 and/or the housing thereof is designed to beflexible in a manner that allows the attaching thereof to people withdifferent contours and/or encirclement, Optionally, the wearablemonitoring apparatus 100 and/or the housing thereof is provided invarious sizes.

The attaching of the wearable monitoring apparatus 100 to the thorax ofthe user allows the user to wear it below a common blouse or a shirt.Optionally, the thin housing, which is designed to contain all theintegral parts of the monitoring apparatus 400, including a processingunit and one or more EM transducers which are designed to implementmonitoring methods, for example as described in co filed patentapplication by Dan RAPPAPORT, Nadav MIZRAHI, Shlomi BERGIDA, AmirSAROKA, Amir RONEN, and Ilan KOCHBA titled method and system formonitoring thoracic fluids which the content thereof is incorporatedherein by reference. For brevity, this application may be referred toherein as the co filed patent application. Optionally, the wearablemonitoring apparatus 100 is connected to a battery, optionallyrechargeable.

Optionally, the wearable monitoring apparatus 100 is attached to thebody of the user 101. Optionally, the wearable monitoring apparatus 100includes a replaceable body coupler that increases the contact betweenthe wearable monitoring apparatus 100 and the user's body and optionallyreduces the skin irritation which could have been caused by the wearablemonitoring apparatus 100.

In some embodiments of the present invention, the wearable monitoringapparatus 100 is designed to continuously track, in a plurality oftransmission sessions, the fluid content n an internal tissue of theuser 101, such as the pulmonary fluid content user. As further describedin the co filed patent application, the wearable monitoring apparatus100 may be used for performing such monitoring for hospitalized and nonhospitalized users during a monitoring period which is longer than 1, 2,4, 8, 12, 16, 20 and 24 hours, days, weeks, mouths, and/or years. Suchmonitoring includes capturing reflections while the user is ambulatory.As used herein, ambulatory means a user which is not confined to acertain location where monitoring is conducted. For example, ambulatoryusers may be monitored for periods which are longer than one hour,without being confined to a certain area and immobilized users may bemonitored for long periods, for example for periods of 24 hours or more,without having to lay in a designated hospitalization room that isequipped with a stationary monitoring device.

In some embodiments of the present invention, the wearable monitoringapparatus 100 is responsible for the continuous and/or repetitivemonitoring the fluid content, and optionally additional clinicallyrelated parameters, in order to indicate a biological and/or clinicalcondition of the user and/or to alert or notify the user 101 and/or theuser management unit 102 about a biological process, such as a wellnessindicative process, a pathological process and/or a cause of a diseasethat is detected according to the detection of an dielectric relatedproperties As used herein, pathological processes, pathologicalconditions, and causes of diseases mean degenerative processes, trauma,atelectasis, post-operative atelectasis, acute respiratory deficiencysyndrome (ARDS), an infectious causes, an inhaled toxins, a circulatingexogenous toxins, a vasoactive substances, a disseminated intravascularcoagulopathy (DIC), a immunologic processes reactions, a uremia, a postdrowning lung water level, a pulmonary venous thrombosis, a stenosis,burns, a veno-occlusive disease, a hypoalbuminemia, an emphysema, alymphatic insufficiency, a high altitude pulmonary edema (HAPE), aneurogenic pulmonary edema, a drug overdose, a pulmonary embolism, aneclampsia, a postcardioversion, a postanesthetic, a postextubation, apost-cardiopulmonary bypass an inflammation progress of ARDS users,postoperative atelectasis and/or any other pathological process and/orcause of a disease with abnormal fluid content in an internal body areaas a symptom or epiphenomenon. As used herein a biological process meansa process occurring in living organism as an outcome of a normal and/orabnormal physical action of the user, such as an athletic activity, forexample hiking. The wearable monitoring apparatus 100 may userepetitive, continuous or intermittent measurements for monitoring ofabnormal biological processes and/or changes in the routine of the user,for example monitoring the effect of a certain physical exertion, a dietand/or an altitude change on the monitored user. Such monitoring mayallow alerting the user about fat to water ratio decrease, prospectivedehydration and/or altitude sickness.

Optionally, the wearable monitoring apparatus 100 is configured forcontinuously monitoring changes in the dielectric related properties ofone or more internal tissues. The reflection of the EM radiation, whichis intercepted by the EM transducers wearable monitoring apparatus 100are analyzed to allow tracking and/or detecting of anatomical,physiological, and/or pathophysiological parameters. Such an analysis,which may be performed locally on the wearable monitoring apparatus 100and/or using a central server, for example as depicted at 102 of FIG. 2facilitate generating a clinical status report and/or alert, for exampleas described below.

Optionally, the analysis allows gathering data, which is based on theintercepted reflections, which reflects a trend, a pathological pattern,and/or one or more deductive or observational measurements that reflecta change in the fluid content of an internal tissue. For brevity, theoutcome of such an analysis may be referred to herein as a change. Inuse, as further described below, such an analysis allows thecommunication interface to send a report that is indicative of thischange and the MMI 207 to present the change and/or an alert which isbased thereon. For brevity, a communication interface and/or unit, asshown at 208, which allows forwarding data, such as the report, to thirdparties, such as the patient management unit 102 and the interrogator152, and a presentation unit, such as the MMI 207, may be referred toherein as reporting unit.

The wearable monitoring apparatus 100 may function as an independentmonitoring device, as a sensing unit of a monitoring system, and/or as amonitoring device that communicates with a central computing unit, suchas the user management unit 102, during a period which is longer than 1,2, 4, 8, 12, 16, 20 and 24 hours, days, weeks, mouths, and/or years, inan intermittent or continuous measurement manner. In such an embodiment,the monitoring device may be used for gathering, and optionallyanalyzing, data, such as dielectric related properties of the internaltissues, such as the pulmonary tissues, and transferring the gatheredand/or analyzed data to the user management unit 102 for producing adetailed report, a notification, and/or an alert.

As used herein, an analysis may include processing any digitized signalof any of sensors, such as the front end sensors which are describedbelow, for alerting, reporting, and/or allowing any other functionalityof the user management unit 102 and/or the wearable monitoring apparatus100, for example for determining one or more clinical parameters, suchas physiological, pathophysiological, and anatomical parameters,determining clinical status of the user, such as a overall health score,determining a specific disease status, determining trends of change,determining a probability of change, and determining one or more alertevents.

Alternatively or additionally, the wearable monitoring apparatus 100 isdesigned for locally analyzing the dielectric related properties ofinternal tissues, such as the pulmonary tissues, in a manner that allowsthe generation of a real time alert, for example as described in the cofiled patent application. In this context, the term “real time” meansthat the time the wearable monitoring apparatus 100 and/or the usermanagement unit 102 takes to output an alert and/or a clinical status issufficiently short not to introduce any significant delay in timebetween the analyzing the dielectric related properties of internaltissues and the generation of a real time alert.

In some embodiments of the present invention, the analysis allowscalculating a biological parameter, such as a clinical state, of a userbased on an integrative index. The biological parameter may bedetermined based on a combination between the dielectric relatedproperties of an internal tissue, such as the pulmonary tissue, and/orfluid content build up pace and vital signs and/or detected trends ofvital signs which are acquired using one or more additional sensors.

Such additional sensors may include sensors such as electrocardiogram(ECG), electromyogram (EMG), an ultrasound transducer, a blood pressuresensor, for example an ultrasonic sensor, a pulse oximeter, activitysensors, for example accelerometers and tiltmeters, microphone,capnometer, a coagulometer and any sensor configured for gathering datarelated to the physical condition of the monitored user. As used herein,a physical condition means data related to the physical activity, vitalsigns, biological parameters, and/or any other medical and/or biologicalinformation which indicative of the user wellness and/or fitness of themonitored user.

The biological parameter, which may be referred to any one or morevalues of biological indicators which reflect a status of a human and/oran organ and/or a tissue thereof, may be determined based on acombination between the dielectric related properties of the monitoredinternal tissue and and/or organ, which optionally are indicative of afluid content and/or a fluid content build up pace and user relatedmedical data, such as medical history, a diagnosis of the treatingphysicians, pathology information and thresholds.

Optionally, biological parameter may be determined based on acombination between the dielectric related properties and additionaldata that is acquired using the EM transducers, such as breathing rateand/or depth and heart rate. Optionally, biological parameter may bedetermined based on a combination between the dielectric relatedproperties user related data from external sources and/or sensors. Suchdata may include real time clock reading, medical and/or physiologicaldata which is updated and/or entered by a caretaker, statistical dataprovided by the user management unit 102, and/or manually inputtedparameters.

The data which is acquired from the EM transducers and/or from theadditional sensors allows improving the accuracy of the acquiredbiological, optionally clinical, parameters by detecting and deducingthe effect of internal and/or external physiological activities of themonitored user. For clarity, effects of internal physiologicalactivities may include heart beat rate, breathing cycle, and/or bloodcycle and effects of external physiological activities may includeeffects of posture change, sweating, and/or external body heat. Forbrevity, different positioning of an internal organ and/or tissue inrelation to the EM transducers may also be referred to herein asdifferent postures.

The integrative index is optionally scaled and/or color coded to provideintuitive follow-up of the clinical status of the user. The medicalsensors may be embedded into the wearable monitoring apparatus 100and/or communicate therewith via a communication interface. In such anembodiment, the wearable monitoring apparatus 100 may determine acurrent clinical state of the user according to various vital signs, forexample according to known multi-parameters pattern classificationalgorithms, such as Bayesian based algorithms and neural networks basedalgorithms.

Optionally, dielectric related properties and/dielectric relatedpropertiesdielectric related propertiesnd/or the vital signs trends arecalculated from recorded and/or logged dielectric related properties ofthe user. In such an embodiment, the dielectric related properties ofthe monitored tissue may be collected during a period which is longerthan 1, 2, 4, 8, 12, 16, 20 and 24 hours, days, weeks, mouths, and/oryears. In such a manner patterns and/or pace of the accumulation and/orchange in one or more dielectric related properties may be detected. Forexample, as described in the co filed patent application, thepathological pulmonary fluid content, which are calculated by thewearable monitoring apparatus, are recorded and used for detectingdielectric related properties, such as an accumulation and/or a presencepace.

As the wearable monitoring apparatus 100 allows monitoring and/ordetecting dielectric related properties and/or a change, such as a fluidcontent change, a pattern of an accumulation and/or a dispersal offluid, within a specific area of interest, a process, such as parenchymain the micro level and/ora change of composition in the macro level of atissue, such as the monitored tissue. Optionally, the monitoring and/ordetection is based on gathered data during one or more transmissionsessions, from one or more front end sensors, and on the analysisthereof for detecting a change caused by a trend, a pathologicalpattern, and/or a gradual process. Such an analysis may be based oncombination of outputs from a plurality of sensors. In some embodimentsof the present application, the gathered data is used for detecting sucha change by arranging data in single and/or multiple dimensional modeland optionally comparing the model to a reference model and/or baselinethat reflect a trend, a pathological pattern, and/or a gradual process.An example for such a model may be a model, such as a 4D model, whichreflects changes in a multi dimensional model, such as a 3D model,during a period. The multi dimensional model may reflect dielectricrelated properties from one or more areas in the monitored tissue, ablood pressure, an activity level, a glucose level, body temperature,body mass, and/or the composition of the fluid content in the one ormore areas of the monitored tissue.

Additionally or alternatively, the wearable monitoring apparatus 100 maybe used for an early detection of pathological exacerbation, tailoredtitration of medical treatments and/or monitoring of the user's clinicalstatus. Optionally, the wearable monitoring apparatus 100 may be usedfor monitoring CHF users for the purpose of detecting the early stagesof decompensation states and/or processes and reduced heartfunctionalities. Such an early detection allows a timely treatment thatalleviates the symptoms and may prevent or shorten the hospitalizationperiod of the user and/or reduce morbidity and/or mortality.

Optionally, the wearable monitoring apparatus 100 is used for improvinga titration and/or a prognosis process. For example, angio-genesismedication, chemotherapy and/or irradiation treatments may be titratedoptimized according to readings of the wearable monitoring apparatus100. The optimization may be performed by adjusting the type, intensityand repeatability of these treatments. Such monitoring allows reducingthe exposure of the user to chemical agents and ionizing radiation byadjusting their amount according to dielectric related properties of themonitored tissue, for example by checking the actual concentration offluids and/or accumulation patterns. Optionally, the monitoring allowsmonitoring the concentration of inflammatory fluids in and/or betweeninternal tissues. Optionally, the monitoring allows evaluating thecomposition of fluids which are accumulated in and/or between internaltissues, for example the concentration of a salt, glucose, an antiinflammatory agent and/or a combination thereof in a certain internaltissue. Such monitoring allows estimating the wellness of the tissuesand/or the pathological condition thereof.

Optionally, the wearable monitoring apparatus 100 is used for alertingthe user and/or a medical center about one or more predefined and/orknown biological patterns. such as pathological patterns of one or moreof the following: a degenerative process, acute respiratory distresssyndrome (ARDS), congestive heart failure (CHF), an atelectasis, apost-operative atelectasis, a postoperative process, an osculatedbronchus, a pulmonary inflammation progress, a pulmonary bloodaccumulation, acute respiratory deficiency syndrome (ARDS), aninfectious causes, an inhaled toxins, a circulating exogenous toxins, avasoactive substances, a disseminated intravascular coagulopathy (DIC),a immunologic processes reactions, a uremia, a post drowning lung waterlevel, a pulmonary venous thrombosis, a stenosis, a veno-occlusivedisease, a hypoalbuminemia, a lymphatic insufficiency, a high altitudepulmonary edema (HAPE), a neurogenic pulmonary edema, a drug overdose, apulmonary embolism, an eclampsia, a postcardioversion, a postanesthetic,a postextubation, and post-cardiopulmonary bypass. The predefined and/orknown biological patterns may include a pattern of a monitoredphysiological activity, such as a physical exertion and/or a predefinedand/or known change that correspond with such a physiological activity.The ability to alert the user and/or a medical center about one or morepredefined and/or known biological patterns may be performed by analerting mechanism which is either implemented on the wearablemonitoring apparatus 100, on a remote medical data center and/or on acombination thereof, for example as described below.

Optionally, the wearable monitoring apparatus 100 is used for monitoringARDS users. In such an embodiment, the wearable monitoring apparatus 100is used for monitoring inflammation progress along the treatment.Optionally, the wearable monitoring apparatus 100 comprises multiplefront end sensors which are used for monitoring, optionally dynamically,the spreading of the inflammation in one or more areas, optionally inresponse to an antibiotic medication treatment.

Optionally, the wearable monitoring apparatus 100 is used for detectinga progression of post operative atelectasis. Such an early detection mayallow the user to prevent exacerbation of the user's condition.

Reference is now made to FIG. 2, which is a schematic illustration of anexemplary system 150 for managing the monitoring of dielectric relatedproperties of internal tissues of one or more users, according to someembodiments of the present invention. The exemplary system 150 comprisesone or more wearable monitoring device 100, optionally as outlined aboveand described below and a user management unit 102, optionally asoutlined above and described below. In some embodiments of the presentinvention, the user management unit 102, which may be referred to hereinas a central server, communicates with the one or more wearablemonitoring devices 100 via a computer network 154. As further describedbelow, each one of the one or more wearable monitoring devices 100 maybe used for analyzing inputs which are received from their front endsensors and to produce one or more alerts and/or reports accordingly.Optionally, the user management unit 102 is designed to receive theinputs which are received from their front end sensors and to analyzeand/or generate reports and/or alerts in a similar manner.

As further described below, the wearable monitoring apparatus 100 may beused for gathering data from one or more sensors, such as EMtransducers. The gathered data is either analyzed for detectingdielectric related properties and/or dielectric related propertieschanges in an internal tissue of the user and/or forwarded for analysisby the user management unit 102.

Optionally, the wearable monitoring apparatus 100 forwards, optionallyperiodically, the gathering data, analyzed or not, to an interrogatordevice 152. The interrogator device 152 may be used for forwarding thedata to the user management unit 102. Optionally, the interrogatordevice 152 forwards, optionally periodically, instructions, updates,and/or reconfigurations from the user management unit 102 to thewearable monitoring apparatus 100.

Optionally, the user management unit 102 controls and manages,optionally technically, the one or more interrogator devices 152, theone or more wearable monitoring apparatuses 100, and one or more usermanagement unit 102. Optionally, the user management unit 102 monitorsthe robustness of the system 150 its operations, allows remoteconfiguration via the network 154, to activate and/or deactivate any ofthe system components. Optionally, the user management unit 102 maycollect clinical data from the wearable monitoring apparatuses 100 orother of the components of the system, analyze collected data, managealerts, maintain and manage a central database containing user clinicaldata, such as current measurements, historical measurements, alerts,analysis outputs, treatment information, user entered information,component statuses, component performances, component version historydata, and system management information. Optionally, the user managementunit 102 may facilitate and control access to the information in thedatabase for authorized system operators, users, and/or caretakers, forexample via remote client terminals 156 which are connected to thenetwork 154. For example, a user may access records which are related tothe outputs of her wearable monitoring apparatus 100 for purposes ofgetting feedback related to medical condition and/or user compliance. Inanother example, the user's caretaker and/or an authorized family membermay access the respective data for doing the same. Optionally, the usermanagement unit 102 may monitor the technical status and/or operation ofthe wearable monitoring apparatuses 100. In such manner, the usermanagement unit 102 may alert the user and/or the caretaker aboutprevious, concurrent, and/or prospective malfunctions of the wearablemonitoring apparatuses 100 Optionally, the wearable monitoringapparatuses 100 are designed to sent, periodically, continuously,randomly and/or upon the occurrence of one or more predefined events,data, such as technical status report, to the user management unit 102.

Optionally, the user management unit 102 may facilitate prioritizationof a medical treatment and/or procedure to users which are managed bythe system 150. The user management unit 102 may allow a priority drivenmanagement of the users according to the inputs which are received fromthe wearable monitoring apparatus 100 and/or the analysis that isperformed by them, for example according to the fluid content in thepulmonary tissue of the monitored users. In use, the user managementunit 102 may display a GUI that includes a list of all users which aremonitored by the system 150. The list may be ordered according tocurrent medical risk values which are given to the users. Optionally,the user management unit 102 may be designed to send an email, aninstant message, an MMS, an SMS, and/or any other digital contentmessage that includes identifiers of users with a medical risk above apredefined threshold to a designated address.

Optionally, the user management unit 102 monitors the functionality ofcomponents of the system 150 and/or the communication among componentsof the system 150. Optionally, if a failure is detected, a technicalalert event is initiated any transmitted to any of the components of thesystem 150 via technical communication channels, as further describedbelow. For example, one of the wearable monitoring devices 100 may bepolled via the aforementioned technical communication channels to ensureits proper previous, current, and/or prospective functionality and/orpositioning, for example by querying the placement unit, which isdescribed below. Similarly, other components of the system could bechecked for proper functionality. Optionally, each one of the componentmay implement a local technical monitoring functionality. If a localproblem is detected it may relay it to any other component of the systemthrough the aforementioned communication channels. The local technicalmonitoring functionality may manage the replacement of the wearablemonitoring devices 100 and/or the battery thereof.

Optionally, the technical communication channels may allow updating thewearable monitoring devices 100 with new operation modes, softwareand/or firmware versions, and/or parameters of monitoring algorithmsand/or any other functional algorithms, initiating measurements.Optionally, the technical communication channels may allow initiating atransfer of data, deactivate the wearable monitoring devices 100,activate the wearable monitoring devices 100, allowing a remote accessto low level memory content, initiating self tests, resetting and thelike.

Optionally, the system 150 is connected to central medical units and/ormedical data centers 155 which are designed to manage medical data thatis related to the monitored users. In such an embodiment, the data thatis gathered by the wearable monitoring apparatus 100 and/or theanalysis, reports, and/or alerts which are based thereon are collectedand/or managed by the central medical units and/or data centers 155,which may be referred to herein as medical data centers 155.

It should be noted that the system's functionality may be implementedusing some or all of the above mentioned components and multiplepartitioning configurations of the functionalities across the componentsare possible, for example as described below. Any of these componentsmay be implemented as a separate device with hardware and software; itmay also be integrated into existing third party devices and softwareapplication. For example, the user interrogator device 152 may beintegrated into a standard hospital monitor, a third party tele-healthgateway in the user's home, or a smartphone or a PDA. In anotherexample, the patient management unit 102 may be integrated into the ITcentral station application used in the hospital.

Optionally, the communication between the components of the system maybe via computer networks, such as 154. Such a communication may be wiredcommunication and/or wireless communication, local, such as betweencomponents which are located in the same room and/or remote, such as thecommunicating of geographically distributed components over the computernetwork 154. This communication may be access controlled and/or securedto protect the privacy of the user's data and the proper technicaland/or clinical operation of the system. Control will be exercised onwho can access which device and which function in the system. Andcontrol will be exercised on which device can communicate with whichdevice.

Optionally, as shown at 160, a number of wearable monitoring apparatuses100 are connected to a certain user. Optionally, one of the wearablemonitoring apparatuses 100 of the same user may function as a masterdevice that communicates with the components of the system as describedabove and concentrate data which is received from the other wearablemonitoring apparatuses 100 of the same user. Optionally, the data whichis acquired from wearable monitoring apparatuses 100 of the same user ismanaged and concentrated in by the user management unit 102.

Reference is now also made to FIG. 3, which is a schematic illustrationof a set of components 200 of an exemplary wearable monitoring apparatus100, according to some embodiments of the present invention.

The exemplary wearable monitoring apparatus 100 which is depicted inFIG. 3 comprises a central processing unit (CPU) and/or a digital signalprocessing (DSP) which may be referred to herein as a processing unit201. Optionally, the processing unit 201 runs a real-time operatingsystem (RTOS) that is responsible for coordinating all functions of themonitoring device 100. The processing unit 201 is optionally used foranalyzing the outputs of the one or more front-end sensors 204 which aredescribed below. Optionally, the one or more front-end sensors 204capture signals which are forwarded to the processing unit 201 thatcalculates medical indices of interest, which is optionally based onphysiological, anatomical and/or clinical parameters. For example, theprocessing unit 201 may compare between the calculated parameters and aset of one or more predefined values and sets flags accordingly, forexample as described below. The data which is calculated by theprocessing unit 201 is optionally used for generating one or more alertsand/or notifications, as further described below and in the co filedpatent application. It should be noted, that the term processing unitmeans a local processing unit, a distributed processing unit, and/or aremote processing unit which is used for performing the functioning ofthe processing unit which is described herein. In an embodiment in whichthe processing unit is remote, the data which is forwarded to theprocessing unit is transmitted for remote processing by the remoteprocessing unit.

The wearable monitoring apparatus 100 further comprises a memory unit202, such as a non volatile memory, that is designed for storing theoperating system and parameters which are needed for the functioning ofthe wearable monitoring apparatus 100. Optionally, the memory unit 202is used for recording readings of reflections from the thorax and/orcalculations which are based thereupon, for example as further describedbelow. Optionally, as outlined above, the dielectric related propertiesof the monitored tissue, such as the fluid contents, for examplepulmonary fluid contents which are calculated according to reflectionsof EM waves from the thorax, are recorded in the memory unit 202. Such arecording allows examining changes in the predefined and/or knownbiological patterns, such as in the pathological pulmonary fluidcontent, along a period that lasts between few hours and days, forexample as outlined above. The recording allows calculating one or morebaselines and/or the identification of a normal range which are adjustedaccording to the specific user. Optionally, the memory unit 202 is usedfor recording readings of medical sensors which are connected to thewearable monitoring apparatus 100 and/or embedded therein. Optionally,the memory unit 202 is used for storing additional information, such asapplication executables codes, configuration files for the processingunit 201, preset parameters, long term state parameters and tables. Thememory unit 202 may be used for storing additional user related data,such as the user identification information, version information, userspecific thresholds, authentication and/or security keys.

The wearable monitoring apparatus 100 further comprises a rapid accessvolatile memory unit 206, such as a dynamic random access memory (DRAM),a synchronous DRAM (SDRAM), and/or any other volatile memory for storingdata that is needed to be accessed in a limited time for short terms. Itmay be interfaced by the processing unit 201, the below mentioneddesignated IC and/or any other component of the wearable monitoringapparatus 100.

Optionally, the wearable monitoring apparatus 100 comprises a designatedprocessing unit 203, such as a designated integrated circuit (IC), forexample an application-specific integrated circuit (ASIC) or afield-programmable gate array (FPGA) that contains logic blocks andprogrammable interconnects which are programmed to implement some of thefunctions required to process the data from the sensors front-ends. Thedesignated processing unit 203 communicates with the processing unit201, the memory unit 202, and/or with other components of the device forvarious tasks. Additionally or alternatively, the designated processingunit 203 may also implement any of the other blocks as an integrativesolution. For example, the FPGA or ASIC may incorporate the processingunit 101 and/or another processing unit. Optionally, the logic blocksare programmed to implement monitoring methods as described in the cofiled patent application.

As described above and depicted in FIG. 3, the wearable monitoringapparatus 100 further comprises one or more front-end sensors 204, suchas EM transceivers, for transmitting a plurality of electromagnetic (EM)waves toward the thorax of the user and for capturing reflectionsthereof from an area of interest, such as the pulmonary tissues of theuser 101. In some embodiment, the beam is transmitted in a desired pulseand allows the capturing of a reflection thereof from various areas onthe surface of the user's body. Optionally, the capturing of areflection is adjusted according a selected operational mode, forexample according to a selected swept frequency, a selected frequencyhopping chirp, and the like. Other modes and/or gating patternsaccording to which the beam is transmitted and allows the capturingthereof are described in the co filed application.

In such a mode, time gating may be used for focusing on a specificreflection, for example as described in the co filed patent application.The shape of the pulse may be generated using different shapingtechniques.

In some embodiments of the present invention, the front-end sensors 204include EM transducers which are designed for transmitting one or morepulses of EM radiation and intercepting the reflections of the EMradiation from monitored tissues and/or organs of the monitored user.Optionally, the monitored tissues are internal tissues, such as thepulmonary tissue. The intercepted reflection is converted to a signalhaving different features that allows evaluating dielectric relatedproperties of the monitored tissues and/or organs, for example asdescribed below. The EM transducers are optionally designed tocontinuously transmitting and analyzing the reflection for monitoringdielectric related properties of the monitored tissues and/or organs,which may be referred to herein, for brevity, as the monitored tissues.

Optionally, in order to achieve high range resolution while keeping theimplementation relatively simple close range detection pulses are used,.The shorter the pulse the higher is the space resolution. Such pulsesare known in the art and therefore not discussed in great detail.

Optionally, the EM transducer is designed to transmit one or more stablefrequency continuous wave (CW) radio signals and then to receive thereflection thereof from internal tissues and/or objects. The one or moreCW radio signals may be transmitted, simultaneously or sequentially. Forexample, the CW radio signals may be transmitted in frequencies such as900 MHz and 2.5 GHz. The CW radio signals may sweep one or morefrequency ranges allowing measuring reflections in wide range offrequencies. CW signals reflections as well as any narrow band signalreflection may achieve high dynamic range by using narrow filteringaround the used frequencies. The narrow filter may track the signal overtime, for example, it may sweep together with the signal.

Optionally, the spatial and/or timing information is extracted by usingmultiple frequencies. Such information is mainly conveyed in thereceived phase of the signal. Optionally where a low number offrequencies which are not well spread over a large bandwidth results ina relatively poor or void time resolution. A single frequency allowsgenerating differential measurements for measuring a movement and/or adisplacement of a tissue and/or an organ by sensing a change over timeof mainly the phase but also the amplitude of the received reflection.When a dielectric coefficient of a tissue and/or an organ changes,mainly the amplitude but also the phase of the reflection mayrespectively change. Multiple CW signals with spatial resolution thereofare indicative to a localized movement and/or displacement and/ordielectric changes.

As described above, the CW radio signals may be transmitted in one ormore continuous or intermittent transmission sessions. In such anembodiment, known changes in internal organs may be used for performingdifferential measurements that may be indicative of dielectriccoefficients of a monitored tissue and/or organ. Examples forphysiological processes during which the changes in the internal organsare known may be heart beat cycle and/or a breathing cycle.

For example, the breathing cycle changes the dielectric coefficient ofthe pulmonary tissue. Such a change affects mainly the amplitude butalso the phase of a CW signal which is reflected from the pulmonarytissue. A record that documents changes in the dielectric coefficient ofthe pulmonary tissue during at least one breathing cycle may be used asa reference for monitored tissues and/or organs, for example monitoringthe fluid content in a monitored pulmonary tissue, for example asdescribed in the co filed application.

In another exemplary embodiment, the dielectric coefficient of apulmonary tissue may be monitored by tracking a differential measurementcalculated based on the reflection from the interface between the lungand the heart during the systolic and diastolic phases of the cardiaccycle. As the movements of the heart are relatively rapid ˜1 hertz (Hz)with respect to posture changes and movement, such a calculation reducethe effects of posture change and movement.

Reflections from the heart through the lung are changed, in phase and/oramplitude, during a systole diastole cardiac cycle. In some embodimentsof the present invention, these reflections are used to evaluate a fluidcontent in a monitored pulmonary tissue. Thus, in order to improve theaccuracy of this evaluation, the effect of the systole diastole cardiaccycle on the reflection has to be taken into account.

Changes in the phase and amplitude of reflections from the heart throughthe lung are indicative of dielectric related properties changes wherethe measurement itself is posture resilient. In particular, the phase ofthe systole-diastole differential measurement is indicative of adielectric change in the lung. Changes in the concentration of fluids inthe lung affect the phase velocity (EM radiation propagation speed) andtherefore may be used for evaluating the fluid content in the lung. Theamplitude of the differential signal is also indicative to dielectricchange in the lung, as a pulmonary tissue with a certain concentrationof fluids absorbs more of EM radiation that propagates therethrough thana pulmonary tissue with a lower concentration. The higher is theabsorptions of reflections the lower are the reflections from the heart.Optionally, the reduced effect of the posture on the reflections isidentified and further reduced using the posture detection methods whichare described below.

In some embodiments of the present invention, the one or more EMtransducers use a simplified narrow band and/or a multiple-band antenna,with one continuous band or several bands, which are matched to themonitored tissue and/or organ. Optionally, a placement mechanism orunit, such as the placement unit which is described below, is used forshifting the matching bands of the antenna according to the positioningthereof Optionally, the CW signals are shifted each separately orjointly, so as to achieve optimal sensitivity to one or more parameter,such as shifts in respiration and heart rates.

Optionally, the CW signals referred to in this patent are equivalent tonarrow-band signals, and all descriptions referred to such CW signalsmay be equivalently referred to the narrow-band signals. As used hereina narrow-band signal means a signal spreading over a small frequencyband, for example up to 50 MHz, optionally modulated and used to expandthe band of the transmitted energy. Such modulation may be frequencyhopping, chirp, frequency-shift keying (FSK), phase-shift keying (PSK),amplitude Shift Keying (ASK) and the like. In such an embodiment, the EMtransducers may de-modulate the reflections to compress the band backbefore further filtering and detection for improved sensitivity anddynamic range.

Optionally, the frequencies of the narrow band signals are 900 MegaHertz (MHz) and/or 2.4 gigahertz (GHz) industrial, scientific, andmedical (ISM) bands. Optionally, two frequencies, such as theaforementioned two frequencies, may be combined to improve timeresolution and/or to separate reflections from neighboring interfaces,or may be used for improved sensitivity. In such an embodiment, thelower frequency penetrates deeper and less sensitive to smalldisplacements. In such an embodiment, radiation in different frequencymay be produced sequentially or simultaneously.

Optionally, narrow-band signals may be used jointly with pulsed widebandsignals so as improve the overall sensitivity and robustness of thetransmission session. As commonly known, a narrow band antenna is moredirective and allow more power to be used for the narrow band signals.Optionally, the pulse wideband transmission may achieve improved spatialresolution while the narrow band signals may improve the penetrationdepth and extract information from deeper layers.

Optionally, the one or more front-end sensors 204 includes additionalmedical sensors, such as an electrocardiogram (ECG), an electromyogram(EMG), ultrasound transducers, pulse oximeters, blood pressure sensors,accelerometers, tilt-meters, coagulometers, and optical blood saturationdetectors.

In one example of the present invention, the wearable monitoringapparatus is attached to the skull of a user and used for monitoring abuild up of intra-cranial pressure which may be a consequence of a headinjury. The device may be focused on a specific location according toinputs from an imaging modality such as an MRI and/or a CT modality,either automatically and/or through a manual user interface.Alternatively, a broad region should be monitored either by a wide rangeof irradiated region from a single device or by a multiple transducersin a configuration as described below. The monitoring period isrelatively short of few days, and the measurements frequency isrelatively high specifically right after initial placement of every fewminutes.

Optionally, the one or more front-end sensors 204 include one or more EMtransceivers which are designed for generating sharp pulses. Optionally,the EM transceivers are connected to and/or include one or moreamplifiers, such as a low noise amplifier (LNA). Optionally, the EMtransceiver having a slim profile that allows the manufacturing of aslim wearable monitoring apparatus 100, for example as depicted in FIGS.4A and 4B.

Optionally, the EM transceiver is designed for sampling pulse signalswhich are echoed from an internal area in the body of the user, such asthe pulmonary tissues, and indicative of the dielectric relatedproperties of fluids, such as water, blood, and/or inflammation fluidstherein.

Optionally, each EM transceiver utilizes one or more antennas fortransmitting and/or intercepting EM signals. Each antenna may beconfigurable by setting antenna controls.

In some embodiments of the present invention, the antenna is a lowreverberation antenna, such as a planar wide band antenna adapted forreducing the effect of reverberations upon the quality of signaltransmission. Such an antenna produces a short duration fast-decayingpulses for improved time and range resolution. Optionally, the antennaterminates the radiation using lumped resistors to reducereverberations, which may be referred to as re-ringing of currents, fromthe far end of the antenna and emulate an infinite antenna, without aneed for printing tapered resistive layers.

Reference is now also made to FIG. 4A, which is a schematic illustrationof an exemplary EM antenna 350 of an EM transducer, such as atransceiver, according to some embodiments of the present invention. Insome embodiments of the present invention, the EM antenna 350 comprisesresistors 351, which are optionally discrete resistors, a fieldtransducer 352, a matching construction 353 and a dielectric substrate354, which is optionally made of a flexible material and supports theconstruction of these components. The dielectric substrate 354 containsany flexible or non-flexible composite material, such as a polymericfilm, paper, a fabric band, a rubber band, and a leather band.

The field transducer 352, which is optionally metallic, is circularplate having a rounded biconic slot, which etched or engraved onto itssurface. Optionally, the field transducer 352 is made of an electricallyconductive material, such as metal and electrically conductive polymericresins. Optionally, the rounded biconic slot 355 forms two round coneswhich are connected with two strips, such as extended strips, which maybe supported by the dielectric substrate. In another embodiment, shownat FIGS. 4B and 4C, a connector, as shown at 355, such as a subminiatureversion A (SMA) connector, is used to connect the antenna and atransition line that leads the current to the center of the antenna. Thecircular plate is farther etched or engraved with two opposing gaps thatallow the assembling of the resistors, such as lumped resistors, lumpedcoils, and/or lumped capacitors thereon. Optionally, the resistors areassembled between the two round cones at the opposing strips ends, forexample as shown at 351.

As the EM antenna 350 comprises discrete resistors, printing ofresistive layers may be avoided and the manufacturing cost of the EMantenna 350 may remain relatively low.

The structure of the exemplary EM antennas, which are depicted in FIGS.4A and 4B, allows the transmitted electromagnetic energy to spread alongthe field transducer 352 with minimal or no disturbance. Theelectromagnetic energy that is not emitted from the EM antenna 350 isabsorbed by the dielectric substrate 354 and optionally converted toheat.

In the antenna which is depicted in FIG. 4A, the matching construction353 is optionally an unbalanced transmission line having an ungroundedconductor that carries electrical current from the power sourceconnected at one apex of one of the round cones that comprise thebiconic slot while a shield is continuously connected between the otherapex of the other round cone and the rounded side thereof. Theunbalanced transmission line is either pulled perpendicularly to thesurface of the field transducer 352 or ended at the point in which thepulse transmitting and intercepting circuitry is assembled. Optionally,the unbalanced transmission line is embedded into a dielectric surface.

The arrangement that is depicted in FIGS. 4A and 4B reduce the ringingeffect in low frequency band. As used herein the ringing effect means adistortion in the form of a damped oscillatory waveform superimposed onthe main waveform of the EM wave that is captured by a respectivetransducer. For example, the EM antenna 350 which is depicted in FIGS.4A and 4B have a reduced ringing effect and decays its pulse byadditional −15 decibel (dB) after 1 nano second (ns) compared withbow-tie antenna.

It should be noted that such an arrangement allows the positioning ofthe EM field transducer 352 concomitantly to the body of the user. Sucha positioning may soften the high back-scatter of energy that is causedby the antenna-skin interface that limits the dynamic range of the EMantenna 350.

Optionally, the antenna can be embedded within dielectric material tofurther decrease its dimensions or to expand its band to lowerfrequencies. As commonly known, a dielectric material improves theantenna performance by scaling of its dimensions. Optionally, the useddielectric material is a high dielectric material that slows the speedof light in an affective manner and allows a reduced size antenna. Sucha reduced size antenna allows reducing the size of the wearablemonitoring apparatus 100.

Optionally, the dielectric material is designed for separating theantenna from the skin and used to improve antenna-body EM wavepenetration as well as reduce strong coupling between the antenna andthe conductive skin. Optionally, the dielectric material is selectedaccording to the thickness of the skin and fat layers of the user in amanner that reduces reverberations in these layers. In such anembodiment, the returning reflected pulse propagating to the antennaexperiences a minimal impedance mismatch of the skin and minimalreflected power returns into the body for a sequential rounds.

Optionally, the antenna may be adjusted to the body impedance of aselected user by selecting matching resistors.

Optionally, the thickness of the EM antenna 350 is below 15 mm. Such aslim construction of the EM antenna 350 allows the generation of a slimwearable monitoring apparatus 100 that may be positioned on the surfaceof the user's thorax 101 relatively without affecting on the ability ofthe user to perform daily tasks, such as dressing, eating, and preparingmeals. Optionally, the antenna can be curved to match the body part. Thecurving may be used to fix the antenna at a certain point on the bodyand reduce or eliminate its movements while the user moves.

Optionally, the EM transducers are adjusted for transmitting andintercepting EM radiation in intermittent data acquisition sessions,which may be referred to herein as transmission sessions. Optionally,the pace of the data acquisition sessions is constant. Optionally, thepace of the data acquisition sessions is random. Optionally, the pace ofthe data acquisition sessions, which may be referred to herein as asampling rate, is adaptive. In such an embodiment, the data acquisitionsession rate, which may be referred to herein as a sampling rate, may bereduced when biological indications, which are monitored by the wearablemonitoring apparatus 100, indicate that the risks for the monitored userdecrease, for example when the monitored tissue is pulmonary tissue andit is less likely that the user develops cardiorespiratorydecompensation. Similarly, the sampling rate may be increased whenbiological indications which are monitored by the wearable monitoringapparatus 100 indicate that the risks for the monitored user increase.Optionally, the sampling rate is determined according to the latesttrend measurements. For example, if the case of slow rate of change of amonitored parameter in a given past period of time, the sampling rate mebe reduced and vice versa. Optionally, the sampling rate is manuallyadjusted by the caretaker, optionally according to characteristics whichare specific to the user. Optionally, the sampling rate is automaticallyadjusted, optionally according to one or more monitored biologicalindications, for example according to a ratio between the user'smonitored biological indications and statistical data which has beengathered from monitoring other users, optionally with similarphysiological characteristics and/or medical condition. For example, ifthe medical condition of the monitored user matches to a New York heartassociation functional (NYHA) class-3 user without pleural effusion, anelectrical implantable device, such as CRT, ICD, and/or a pacemaker, anda renal deficiency, the sampling rate is set to a data acquisitionsession of 3 minutes every 6 hours. Optionally, the sampling rate isupdated automatically, according to changes in the medical condition ofthe user.

In some embodiments of the present invention, the wearable monitoringapparatus 100 is designed for hosting and/or accessing a tissue model,such as the chest model, which is described in the co filed application,or other body part model. The tissue model may define the range ofnormal as well as abnormal dielectric related properties in differenttissues, their dimensions and/or respective spatial configurations, andused in the analysis of the EM reflected signals as described above andbelow and in the co filed patent application, for example for detectingsymptoms, predefined biological patterns and/or pathological patternsand/or changes, for example as described in the co filed patentapplication.

Optionally, the wearable monitoring apparatus 100 is designed foreliminating the effects of the movements and/or changes of postures onthe analysis of the measured EM reflected signals and determination ofthe biological parameter of the user. In some embodiments of the presentinvention, the wearable monitoring apparatus 100 is designed for gatingthe inputs of the one or more front-end sensors 204 for example asdescribed in the co filed patent application. For example, the wearablemonitoring apparatus 100 may be used for allowing the selection ofreflection segments which are received from areas of interest having astatic or dynamic location in relation to the wearable monitoringapparatus 100, for example as an outcome of physiological processes suchperiodical breathing cycle and/or heart beat pace, for example asdescribed in the co filed patent application.

In some embodiments of the present invention the wearable monitoringapparatus 100 is designed for eliminating the effects of the movementsand/or changes of postures on the analysis of the measured EM reflectedsignals and determination of a biological parameter of a user, forexample as described in the co filed patent application. In such anembodiment, the wearable monitoring apparatus 100 comprises one or moreposture detection sensors (not shown), such as accelerometers andtiltmeters, which provide data for classifying the current postureand/or activity level of the monitored user and/or for detecting achange on the posture of the user. In such an embodiment, the posturedetection sensors may be connected to the processing unit 102 andutilize it for calculating the current posture and/or a change in theposture.

Optionally, the wearable monitoring apparatus 100 detects the posture ofthe monitored user and movements by analyzing the EM reflected signalsas described below. In such an embodiment, data related to posture,movement, and/or activity of the monitored user may be used foridentifying a period for performing a data acquisition session, such asthe data acquisition sessions which are described below. In such amanner, biological indications, such as dielectric related properties,which are related to the monitored tissue of the monitored user may beacquired while the user performs an activity during which she is in highrisk and/or while the data may be acquired in the most accurate and/orproductive manner. For example, performing a data acquisition sessionmay be triggered by the wearable monitoring apparatus 100 when themonitored user is undergoing high physical exertion and/or while themonitored user is at rest.

In some embodiments of the present invention the wearable monitoringapparatus 100 is designed for analyzing the EM waves which are receivedfrom the front end sensors 204 according to the frequency thereof Forexample, high frequencies may experience changes resulting from amonitored physiological phenomenon, for example due to frequencydependent dielectric change. For example, fluid accumulation in the lungresults in a stronger absorption of the higher frequencies. Thefrequencies may be analyzed according to wavelet transforms thatprovides frequency ranges and/or locality in time.

Optionally, the wearable monitoring apparatus 100 is connected to apower supply element circuitry 205 that is designed for generating anddistributing the power supply that is required for the components of thewearable monitoring apparatus 100.

The power supply element circuitry 205 comprises one or more batteries,optionally rechargeable.

Optionally, the wearable monitoring apparatus 100 comprises aman-machine interface (MMI) 207 for presenting data, such as an alert, anotification, statistical data, a current reading of the one or morefront-end sensors 204 or external modality to the user, the user'scaretaker, and/or others as desired. The MMI 207 may comprise a liquidcrystal display (LCD), a touch screen, a speaker, a tactile generator, aset of light emitting diodes (LEDs), and/or any other indicator that maybe used for presenting alerts and/or notifications which are based on acombination of the analysis of reflections of EM waves from an internalarea in the body of the user, such as the pulmonary tissues, andindicative of the dielectric related properties of fluids, such aswater, blood, and/or inflammation fluids therein and other parameterscalculated based on the EM reflections and\or the integrated or externalsensors. Optionally, the configuration of the wearable monitoringapparatus 100 may allows the user and/or a caretaker to define whichalarm to present, for example whether the alarm is visual, audible,and/or tactile.

For example, when an alert is initiated as an outcome of theimplementing of the aforementioned logic blocks the MMI 207 sounds analert using one or more speakers and displays an appropriate message onan LCD display thereof.

Alternatively or additionally, an MMI 207 which is configured to performthe aforementioned functionalities is connected to a remote unit thatcommunicates with the wearable monitoring apparatus 100, such as theaforementioned interrogator device 152 and/or any component of the usermanagement unit 102.

Optionally, the MMI 207 and/or the MMI of the remote unit is connectedto an input unit, such as a keyboard, a keypad, a touch screen and/orany other unit that allows the user, the user's caretaker, and/or othersas desired to configure the wearable monitoring apparatus 100, adjustthe MMI 207, make selections, and/or change modes of the MMI 207.Optionally, the MMI 207 and/or the MMI of the remote unit allows themonitored user to activate and/or deactivate the wearable monitoringapparatus 100, snoozing an alert, presenting the gathered data on whichthe alert is based, changing operational mode and the like.

Alternatively or additionally, the MMI 207 is configured for notifyingthe user when a battery replacement is necessary. Optionally, the MMI207 uses the outputs of a placement unit 210, for example as describedbelow, for guiding the user during the process of repositioning thewearable monitoring apparatus 100 after the battery replacement, forexample by providing voice commands.

In some embodiments of the present invention, the wearable monitoringapparatus 100 is disposable. In such an embodiment, the MMI 207 mayindicate to the monitored user when and optionally how to replace thewearable monitoring apparatus 100. Optionally, the placement unit isused for instructing the monitored user during the positioning of thewearable monitoring apparatus 100, for example but indicating to themonitored user when it is accurately positioned.

Optionally, the wearable monitoring apparatus 100 is integrated and/ordesigned to be integrated into a garment, such as a chest strap, ashirt, a vest, a hat, a sticker, pants, underwear and the like.Optionally, the wearable monitoring apparatus 100 is divided todisposable and reusable parts. The disposable part may include thebattery, an attachment unit for attaching the wearable monitoringapparatus 100 to the body of the user, and/or any other electroniccomponent that may be worn out by the use of the wearable monitoringapparatus 100.

Optionally, the wearable monitoring apparatus 100 is designed toperform, either automatically and/or according to a request from theuser management unit 102, a maintenance activity.

Optionally, the wearable monitoring apparatus 100 comprises acommunication module 208 that allows a user, a caretaker, and/or anyother authorized monitored user to configure and/or update thresholds,user related data, and/or any other data which is related to thefunctionality of the wearable monitoring apparatus 100 from a remoteclient terminal or a communicating computing unit, for example via theuser management unit 102, an interrogator device 152, and/or clientterminal which is connected thereto. As used herein a client terminal isa personal computer, a cellular phone, a laptop, a personal digitalassistant (PDA), and/or a Smartphone.

Optionally, the configuration comprises a set of initial parameters,such as the medical condition of the user, medical history related tothe user, the age of the user, the severity of the user's condition, theweight of the user, the height of the user, an approximation of theuser's chest diameter, and an indicator for one of the area selected forthe apparatus. This configuration allows the adjusting one or moredynamic alert thresholds and/or any other characteristics of thealerting mechanism. Such an alert threshold may define the conditionsfor the activation of an alert for the user, the dosage control unit,and/or notifying a medical center about the data that has been gatheredusing the one or more front-end sensors 204. Several alerts thresholdmay be defined in a manner that allows a graded alerting, controlling adose amount in a graduate manner, and/or notifying a severity ofdiagnosis, for example as described in the co filed application.

Reference is now made, once again, to FIG. 2. In some embodiments of thepresent invention, the remote client terminals 156, the medical datacenter 155, and/or the MMI 207 of the wearable monitoring apparatus 100may be used for configuring the thresholds. Optionally, a technicalcommunication channel is established between the remote client terminals156, the aforementioned interrogator device, the aforementioned patientmanagement unit, and/or the medical data center 155 and each one of thewearable monitoring apparatuses 100 and allows transference, optionallybidirectional, of data and/or instructions. In such an embodiment, thetechnical communication channel may utilize a caretaker to adjust thealerting thresholds. For example, a caretaker may be able to use aclient terminal for adjusting a threshold for a user for whom falsealerts are activated. In another example, the caretaker selects and/orchanges an operational mode in a manner that may adjust the thresholdsto the requirements of different routines, such as hospitalized mode,ambulatory mode, sleeping mode, and/or sport mode, unstable mode, and/oraggressive treatment mode. The term ambulatory may be used fordescribing different levels of motorial abilities, such as a partlyambulatory users which have the ability to walk freely in a limited paceand/or with a support, semi ambulatory users which have the ability towalk freely in a limited pace, and fully ambulatory which have theability to walk, run, and/or jump freely, in various paces.

In some embodiments of the present invention, the remote clientterminals 156, the medical data center 155, and/or the MMI 207 of thewearable monitoring apparatus 100 may be used for adjusting and/ordefining the alerting mechanism. Optionally, the alerting mechanism ispart is of the analysis of the outputs of the aforementioned front endsensors and/or biological information that is related to the monitoreduser, such as physiological, anatomical, and clinical data related tosaid user. Optionally, the multiple alerts are defined based on partand/or all of the data that is received from the front end sensorsand/or medical databases and sources which are related to the user.

Optionally, the alerting mechanism is configured to trigger thepresentation of an alert on the wearable monitoring device and in a setof plurality of different client terminals, medical centers andstations, such as the remote client terminals 156, the medical datacenter 155, the patient management units, the interrogator devices,and/or the MMI 207. The set of plurality of different devices andstations may be reconfigured by authorized members. New members, such asany client terminal of the user, a remote caretaker, a local caretaker,a selected family member, an affiliated person, a staff member of callcenter, a nurse, a and the like may be added.

Optionally, the alerting mechanism is designed for sending an email, aninstant message, an MMS, an SMS, and/or any other digital contentmessage for alerting the user and/or a caretaker. In such an embodiment,the user, the caretaker, and/or a system operator may enter an addressidentifier, such as a phone number, an email address, and/or an IMmonitored user name to which the alerting messages will be sent.Optionally, the alerting mechanism is designed for triggering the alarmwhich may be put in a snooze mode by the user and/or the caretaker. Forexample, the user may snooze an alert indicated to him by an audiblesignal for duration of an hour. Once she has contacted her medicalcaretaker the caretaker may direct the user to increase his medicationand snoozes the alert to different optionally longer durations.

Optionally, the wearable monitoring apparatus 100 comprises acommunication interface 208 for establishing a connection, optionallybidirectional, with the user management unit 102, and/or with theinterrogator unit. The connection allows the wearable monitoringapparatus 100 to transfer that data that is stored in the memory unit206. Optionally, the communication interface 208 is based on wiredconnection, for example a universal serial bus (USB) interface.Alternatively or additionally, the communication interface 208 isconnected to a wireless data interface, such as an example an infrared(IR) interface, a wireless fidelity (Wi-Fi) interface, a Bluetooth™module, a electromagnetic transducer module, a universal asynchronousreceiver transmitter (UART) and the like. Optionally, the connectionallows the wearable monitoring apparatus 100 to report on a malfunctionin one of one or more front-end sensors 204 and on any other malfunctionin the monitoring of the dielectric related properties of fluids in aninternal area of the user's body's, for example in the pulmonary tissuesof the user 101. Optionally, the communication interface 208 is used forsupporting the configuration of the device, for example by allowing theuploading of state parameters, version control software elements forupdating firmware and software components, and for reporting current andrecorded information such as clinical parameters such as heart rate,breathing frequency, edema condition, and/or any parameter measured byone of the aforementioned sensors, and any parameter or data calculatedbased thereupon.

Optionally, the wearable monitoring apparatus 100 is designed tocommunicate with the user management unit 102 and/or an interrogatordevice 152, as outlined above and described in the co filed patentapplication.

Optionally, the wearable monitoring apparatus 100 is connected to adosage control unit (not shown). The dosage control unit may beintegrated, in a detachable or fixed manner, into the wearablemonitoring apparatus 100. Optionally, the dosage control unit isdesigned to control the dispensing of a medication. Optionally, thewearable monitoring apparatus 100 is designed to generate a treatingdosage recommendation according to the measured dielectric relatedproperties, vital signs, and/or any other data which has been capturedby the front end sensors or available otherwise. The treating dosage maydefine a change in the quantity and/or frequency of a certain treatment.Optionally, the wearable monitoring apparatus 100 changes the manner thedosage control unit controls the dispensing of a medication according tothe defined change and/frequency.

Optionally, the wearable monitoring apparatus 100 is connected,optionally wirelessly to a control unit (not shown), such as a valve ina system for assisted ventilation of patients and for administration ofanesthetic gas, based on the estimations of the breathing depth and thedegree of the independent respiration muscle operation. Examples ofventilation techniques include positive airway pressure (CPAP), assistedor controlled ventilation and intermittent mandatory ventilation, amongothers. In use, the patient's lungs are ventilated by cycling airwaypressure between ambient atmospheric pressure and some higherventilation pressure. During the high pressure phase of the cycle, thelungs are inflated with the breathing gas mixture supplied by thesystem. During the ambient pressure phase, the lungs deflate as thepatient spontaneously exhales the gas into the atmosphere or othersuitable exhaust facility. Optionally, the valve control unit isdesigned to control the opening and/or closing of the valve and/or thesize of its orifice. Optionally, the wearable monitoring apparatus 100is connected, optionally wirelessly to an implanted medical device. Insuch an embodiment, the communication interface 208 may be used fortransmitting and/or forwarding instructions to the implanted medicaldevice according to the detected change, for example according to adetected change in dielectric related property.

Optionally, the dosage control unit is designed to control or provide afeedback to treatments in oncology, such as irradiation therapy,chemotherapy, anti angio-genesis therapy, and the like. In such anembodiment, the communication interface 208 may be used for transmittingand/or forwarding instructions to the dosage control unit and/or to apresentation unit that present a recommended dosage and/or medicament tothe user and/or to a treating medical personnel. Optionally, the dosagecontrol unit is designed to provide data regarding the effectiveness ofthe treatment in the current posture of the patient and/or placement ofthe wearable device, and providing a feedback regarding the frequency ofthe treatment and the dosage in use. Moreover, it may be used to providea feedback regarding the peripheral damage to a normal tissue as aconsequence of the treatment. This feedback may be used for directinginstructions and may be based on the dielectric related properties,changes and/or patterns which are calculated by the designatedprocessing unit 203, according to intercepted reflections and integratedand external sensors.

Optionally, the wearable monitoring apparatus 100 communicates,optionally wirelessly, with one or more other wearable monitoringapparatuses which are used for monitoring dielectric related propertiesof fluids in other internal tissues of the body of the monitored user.

Optionally, the wearable monitoring apparatus 100 may be placed inseveral positions in relation to the user's thorax 101. A location forpositioning the apparatus may be selected such that the pulmonarytissues are monitored during a full breathing cycle of the user 101. Forexample, the position may be in front of the fifth and sixth ribs, atthe right mid axillary line, for example as shown at FIG. 5. It shouldbe noted that positions in which the lungs wall is monitored in portionsof the breathing cycle may also be selected.

In some embodiments of the present invention, the wearable monitoringapparatus is designed to beam different areas of interest of the thoraxfrom different angles. Optionally, the wearable monitoring apparatusincludes a number of different antenna elements which are spaced fromone another. Such a spatial diversity allows separately focusing on oneor more of the areas of interest and improves spatial and timeseparation in transmission and/or reception. Optionally, the ROI maychange according to one or more physiological activities such asbreathing. Optionally, a tracking mechanism is used to adaptively changethe phase and amplitude of one or more of the antenna elements.Measurements of two or more areas may improve relative measurementswhich are used as an informative feature for posture cancelation and/orphysiological parameter extraction, as explained below.

Optionally, a number of transducers are directed to capture reflectionsfrom a common tissue. In such an embodiment, the captured reflectionsmay be combined for improving the lungs dielectric coefficientsensitivity.

Separating the angle of transmission from the angle of reception reduceseffects of undesired near antenna changes, such as movements and posturechanges. The reception from a transmission path results in a relativelystrong reflection from the near antenna layers. A change in such a layermay override important information from an internal tissue in the body.Two or more transmitting and receiving elements may reduce the strengthof the reflection received from layers which are close to the antennawhile giving more weight to reflection from the internal tissues.

The positioning of the number of different antenna elements may beadjusted for specific suspected pathologies. For example, for monitoringco-morbidities of heart failure and chronic obstructive pulmonarydisease (COPD), designated antenna may be located in front of the rightupper pulmonary segment and the lower left pulmonary segment. Suchantenna elements allow the detection of differences of congestion levelsbetween different segments, for instance by a function of posture and/oractivity which may assist in the diagnosis of the current etiology ofthe fluid congestion.

Reference is now made, once again, to FIGS. 1 and 2. In some embodimentsof the present invention, the wearable monitoring apparatus 100 isdesigned for detecting the posture and/or the activity of the user,thereby to generate clinical parameters that take into account theposture of the monitored user.

Reference is also made to FIG. 6A, which is a flowchart 450 of a methodfor using EM radiation for alerting a user, and the posture detectionblock 450 detecting a posture of a user, according to some embodimentsof the present invention. FIG. 6A depicts, inter alia, exemplary modusoperandi of the posture detection unit 211, which is depicted in FIG. 3.

Optionally, the wearable monitoring apparatus 100 is designed foridentifying postures based on dielectric related properties of internalorgans and/or tissues as extracted from the analysis of the EM reflectedsignals and/or other outputs of other sensors. In the EM-based posturedetector case, posture may be defined as the relative position of theradiating element and monitored internal or external organ. As shown at452, data from the one or more EM transducers is received at thewearable monitoring apparatus 100. Optionally, additional data 441 fromthe front end sensors 204 and/or from external data sources 443, suchmedical data about the user from medical databases is gathered. As shownat 454 the medical data may be stored and/or received from the memory ofthe wearable monitoring apparatus 100. The data 441-443 may be receivedsimultaneously, sequentially and/or interpedently.

Optionally, the EM radiation 442, such as the aforementioned reflectedsignals, and the additional data 441, 443 is processed, as shown at 455to allow the extraction of features therefrom, for example as shown at456. A feature may be based on the morphology and/or timing of thereceived EM signals. For the posture detection functionality featuresindicative to the posture are extracted, such features may include forexample the reflected signal gated to the near-antenna layersreflections, assumed to have strong posture indication. Other featuresare extracted for the purpose of measuring the dielectric relatedproperties of the desired organ and used in 459. These features areindicative to the measured tissue and/or organ dielectric relatedproperties. Some of them are sensitive to posture changes and some aremore resilient. Examples of features that may be used for postureclassification and acquired by analyzing reflections of EM radiationsare morphologies reflections, amplitudes, positions of peak of signalsfrom reflections of selected tissue boundaries, such as fat-muscle,lung-heart, and muscle-lung, differences of amplitudes in signals whichare based on reflections and/or peak positions, either among differentsegments of the signal or between signals measured at different timeinstances, for example amplitude difference of the reflection receivedfrom lung-heart boundary in a signal measured in the time instance ofcontraction, compared to a signal measured in the following relaxation;or similarly for the muscle-lung boundary during end-expiratory andend-inspiratory time instances. Optionally, frequency domain featuresmay be extracted from the EM reflection, like amplitude and phaseresponse of a gated signal, where the gating may localize a reflectionfrom a specific interface between tissues. In some embodiments one ormore features may represent EM reflections of narrow band signals,described earlier, like phase and amplitude. Optionally, one or morefeatures may represent information extracted from the external sensors.

As shown at 457, the extracted features may be used for classifying theposture of the monitored user. In use, the current posture of themonitored user may be found by a match between signals received from theone or more EM transducers and/or an analysis thereof and a value, afeature, a pattern, and/or a range from a posture bank 458.

Optionally, the posture bank 458 includes a scale of values, or a rangeof values, of exemplary features, and/or a combination of features.Optionally, the each value or range in the scale is associated with atag of a selected posture. Optionally, during the classification theidentified features are matched with the class values in the scale. Thematching may be performed using known matching methods. Optionally, eachclass value is generated using known supervised and unsupervisedlearning algorithms. These matching, clustering and/or classificationalgorithms are known in the art and therefore not elaborated herein ingreater detail.

Optionally, the posture classifier and grouping, 457, may output softdecisions like the probability of each known posture to be the currentposture. Its output may be regarded as a feature for any followingclassifier or estimator, such as the measuring dielectric relatedproperties block 459.

Features which are posture resilient can be used to relax the demandsfrom the posture detector and achieve improved dielectric relatedproperties and measurement sensitivity.

Such features are required to be highly sensitive to measured tissueand/or organ dielectric related property, while being less affected byother changes like posture changes. For example, features extracted fromdifferential signals, where differential signals are referred to as thedifferences between two or more signals measured during a short periodof time as elaborated above.

Different postures may be identified according to their effect on thepattern of signals which are reflected from different areas in the body.In one exemplary embodiment the wearable monitoring apparatus 100 isused for measuring dielectric related properties of the pulmonarytissues, for example as described in the co filed application, and theextracted feature is the position of the highest peak in a differentialsignal based on EM radiation reflected from the thorax. In thisexemplary embodiment, the position of the peak is indicative of arelative position of the muscle-lung boundary and therefore may be usedfor classifying the posture of the user. Optionally, the amplitude ofthe same peak may be used as a feature for measuring the dielectricrelated properties of the lung, due to its sensitivity to the dielectriccoefficient of the lung.

Optionally, the posture detection based on the EM reflection from anexit boundary between tissues. This may promote the sensitivity androbustness for the measurement of the dielectric coefficient of themeasured tissue due to the propagation of the EM radiation in and outthe measured organ as well being reflected from a reference tissueand/or organ. For example, measuring a differential signal between thesystolic and diastolic phases, and analyzing the reflection from thelung-heart interface.

The posture detector is used for reducing changes to the EM reflectionsdue to dielectric related properties changes as a consequence ofpostures changes. In some aspect of the invention this functionality ofthe posture detection may be referred to as posture compensation. Insome embodiments of the present invention the posture detection is basedon a tissue model which has been adapted according to the reflectionsignals. Optionally, the expected reflection signal is used as abaseline and a difference between the baseline and a signal which isbased on the actual measured reflections is analyzed to extract changesand/or values which are related to the dielectric related properties ofthe monitored tissue and/or organ dielectric related properties.Optionally, the estimated model is calculated according to data acquiredby EM sensor a non EM sensor, such as an ultrasound imager, computerizedtomography (CT) and/or magnetic resonance imager (MRI). The model is asimplified one-dimensional, a two dimensional (2D), three dimensional(3D) model and/or four dimensional model and so on and so forth. Theestimated model may be used for compensating for the posture effectprior to the processing of the signals 455, and/or prior to the featureextraction 456, and/or prior to the posture classification andclustering block 457 and/or the measuring of dielectric relatedproperties 459. The model based posture compensation can reduce postureeffect on some or whole of the measured reflection signals, therefore,improving posture detection statistics and reduces posture variance.

In some embodiments of the present invention, as shown at 459 anddescribed above, the wearable monitoring apparatus 100 measures and/ormonitor dielectric related properties of internal tissues and/or organsaccording to segments of a signal that is based on reflections fromtissue boundaries of the monitored tissue and/or organ and/or otherreference internal tissues and/or organs. These signals may be monitoredover a period and/or in multiple discrete instances or in a singleinstance. As described above, the posture classification 457 may be usedfor reducing and/or removing the effect of the posture on thecalculations which are based on the dielectric related properties ofinternal tissues and/or organs. In such a manner, alerts and/or thereports which are based on the dielectric related properties, forexample as shown at 460, may take into account the effect of the postureof the user. In such a manner, the number of false alerts may be reducedand the reports may provide a more accurate and complete presentation ofthe medical condition of the user. Optionally, user specific alert arealso generated according to the posture detection, for example withrespect to a treatment which is adjusted for the user. In such anembodiment, the device may be used for monitoring the movement of theuser and to reduce harm that the user may cause to her, to the progressof a given treatment, and/or for a monitoring process by the biologicalprobe.

The detection of the posture of the monitored user allows taking intoaccount the effect of the posture on the dielectric related propertiesof the monitored pulmonary tissue, for example by normalizing thevalues. In such an embodiment, the aforementioned biological parametersreports and/or alerts do not ignore the effect of the posture of theuser on the measured clinical parameters.

In some embodiments of the present invention, the posture detection isused for guiding the monitored user to get into at an optimal, orsubstantially optimal, posture before and/or during a monitoringsession. Optionally, the guiding may be used for instructing the user tochange posture in an automatic diagnosis and/or treatment that isperformed by the wearable monitoring apparatus 100 and/or anothermonitoring apparatus. Optionally, the MMI 207 implements an interactiveprocess during which the user tunes her posture until reaching theoptimal, or substantially optimal, posture and/or moves through severalpostures.

Optionally, the MMI 207 includes a minimal monitored user interface,such as a single push button and/or minimal number of audible and/orvisual signals.

For brevity, all the features and embodiments which are described hereinwith regard to the wearable monitoring apparatus 100 may be used by theposture detection unit when used for detecting postures of users thatwear other wearable elements and/or probed by various biological probes.

Reference is now made to FIG. 6B, which is a flowchart 470 of a methodfor using EM radiation for detecting the placement, misplacement and/ordisengagement of a biological probe, such as the wearable monitoringapparatus, according to some embodiments of the present invention. FIG.6B depicts, inter alia, exemplary modus operandi of the placement unit210, which is depicted in FIG. 3. Blocks 450-461 are as described inFIG. 6A, with respective changes for placement, misplacement, and/ordisengagement monitoring and/or detection. However FIG. 6B depicts fewfunctions and/or processes which are related to misplacement and/ordisengagement of a biological probe.

Optionally, the wearable monitoring apparatus 100 comprises a placementunit 210 for monitoring the positioning of the wearable monitoringapparatus 100 on the body of the user. Such a monitoring allowsdetecting a displacement of the wearable monitoring apparatus 100 and/oralerting the user and/or a remote caretaker when the wearable monitoringapparatus 100 is displaced and/or intentionally and/or unintentionallychanges a position.

It should be noted that such a placement unit 210 may be used formonitoring placement and/or displacement of various monitoring andtherapeutic devices, such as imaging modalities, for example ultrasoundimaging modalities, stationary and/or mobile biological probes, and/orany other monitoring device which the positioning thereof on the body ofthe patient has an effect on the receptions and/or outputs thereof. Insuch an embodiment, the placement unit 210 comprises a memory element,such as the memory element which is depicted in FIG. 3 and describedabove, for storing one or more reference values each indicative ofexemplary reflection of EM radiations delivered to the monitoredinternal tissue of the user and/or one or more exemplary dielectricrelated properties. Optionally, the reference values are stored in apositioning bank, for example as shown at 472. Such reference values,which are optionally ranges of values, represent the values which aresupposed to be reflected from the monitored tissue. The placement unit210 comprises and/or connected to one or more EM which deliver, from themonitored wearable element, EM radiation and intercept the actualreflection thereof. The placement unit 210 comprises processing unitand/or configured to use the processing unit of the monitored wearabledevice. The processing unit is used for identifying and/or classifyingthe misplacement, placement, and/or disengagement, as shown at 471,optionally by comparing between the reference value and the actualreflection. For brevity, all the features and embodiments which aredescribed herein with regard to the wearable monitoring apparatus 100may be used by the placement unit 210 when used for monitoring theplacement and/or displacement of other wearable elements and/orbiological probes.

Optionally, the placement unit 210 is used for monitoring the initialplacement of the wearable monitoring apparatus 100. Optionally, theplacement unit 210 is used for monitoring the positioning in a periodicor continuous manner. Optionally, as depicted in 460 the placement unit210 is designed for alerting the user and/or a medical center whendisengagement and/or an improper functioning of the wearable monitoringapparatus 100 are detected. Such an improper functioning may be anoutcome of a low power, a system failure, and/or corrupted and/orunintelligible readings of the one or more front end sensors. Forexample, if disengagement is detected, the MMI 207 is instructed,optionally automatically, to alert to the user and/or a medical center.Optionally terminate other functionalities of the device, such astransmission and/or reception shut down. This functionality enablesavoiding undesired EM emissions to air and a situation in which thedevice is not properly coupled to the body. If the placer identifies asuspicious change in reflection it may terminate transmission sessionsor reduce power to the minimum required for detecting reflections fromlayers which are positioned in proximity to the antenna. When thereflection from these layers matches to an expected reflection, thetransmission power may be raised gradually.

The placement, misplacement and/or disengagement detection, which may bereferred to herein, for brevity, as placement detection, is based on thedetection of an unexpected change and/or an irregular pattern.Optionally, one or more control patterns and/or values are defined asfeatures in 456, in order to allow the monitoring of the disengagementdetection.

Optionally, the disengagement is detected when the pattern of featuresextracted from the received reflections from the front end sensors 204substantially differ from the pattern of features which is expected tobe received at the position of the wearable monitoring apparatus 100. Asdescribed above, the wearable monitoring apparatus 100 is designed to bepositioned in one or more areas. The configuration of the wearablemonitoring apparatus 100 allows the user and/or a caretaker to enter theposition of the wearable monitoring apparatus 100. This position may beused for selecting a model, such as the wall chest model that isdepicted and described in the co filed patent application that isadapted thereto.

In such an embodiment, the disengagement is detected if the data whichis received from the front end sensors 204 does not match the adjustedmodel.

Optionally, the disengagement and/or misplacement is detected when thedata which is received from the front end sensors 204 does not expressan expected physiological process, such as a breathing cycle, the paceof the heart beats, and/or any other process that have detectable effecton the backscatter of EM waves which are emitted toward the front endsensors 204. For example, when the front end sensors 204 are attached tothe chest, it is expected that the acquired signal is modulated by thebreathing cycle which affects the dielectric coefficients of the lung.

Optionally, the disengagement and/or misplacement are detected when thedata which is received does not match a set of reference records. Insuch an embodiment a set of reference records is recorded, automaticallyand/or manually, after a proper positioning of the wearable monitoringapparatus 100. The recorded set of reference records is used forgenerating a reference pattern that a deviation therefrom may be usedfor detecting disengagement.

Optionally, the disengagement and/or misplacement are detected when thedata which is received does not match a predefined range of valuesdefined for each feature.

Optionally, the placement unit 210 is designed to report the positioningof the wearable monitoring apparatus 100 and/or the accuracy of thepositioning of the wearable monitoring apparatus 100 to a remote clientand/or server, for example using the aforementioned technicalcommunication channels, which are described in relation to FIG. 2.

Optionally, the placement unit 210 estimates the quality of thepositioning in reference to prior measurements recorded in memory orexpected reflections. It may measure specific features and compare themto the references or the actual measurement. It then notifies the userand the algorithm of its findings.

A manual search for the correct position may include sliding the devicein different directions on the body until a fixed visual and/or audibleis heard.

Optionally, the placement unit 210 is connected to a mechanicaladjustment unit for automatically changing the position of the wearablemonitoring apparatus 100, the one or more transducers thereof and/or anyother biological probe, in relation to the body of the user. Themechanical adjustment unit may include an actuation unit that comprisesone or more motors, gearwheels, and ratchets for automatically adjustingthe extended strips, and/or any other attachment elements which areconnected to the wearable monitoring apparatus 100.

In some embodiments of the present invention, the monitoring isperformed by placing the apparatus for short period repetitivemonitoring sessions, for example a monitoring session of 5 minutemeasurement a once, twice, and or three times a day.

It should be noted that the posture and/or the engagement, placement,and/or misplacement processes may be used during the calculation ofvalues which are related to intervening tissues, for example fornormalizing their values.

In some embodiments of the present invention, the monitoring apparatusis designed as disposable device which is designed to replace and/orbeing replaced by a similar monitoring apparatus and/or with a placementunit that allows repositioning it after performing a maintenanceactivity, such as replacing a battery and/or cleansing. In suchembodiments, the monitoring apparatus is designed to be placed and/orreplaced, optionally a number of times, in a predefined position inrelation to a reference internal tissue of the body of the user. In someembodiments, the monitoring apparatus may be wearable, as shown at 100,and/or designed to be taken off intermittently, for example, forconvenience reasons and/or for allowing the replacement and/or fixing ofa component due to wearing-off of the package, an adhering material usedfor attaching the monitoring apparatus or a portion thereof to the body,and/or a battery. As described above, the functionality, configuration,and/or use case of the monitoring device may depend also on user postureand/or internal tissue position. For example, a biological sensor suchas the EM pulmonary content fluid sensor described in herein and in theco-filed patent application.

During a placement processing, the posture detection unit may use priorposture positioning data, optionally stored as records of theaforementioned posture bank 458, as reference data indicative of theposition to which the posture detection unit should be replaced.

Optionally, the placement unit may detect a misplacement of the deviceafter being worn, for example, due to movements of the user and/orwearing off of the glue. Where the placement unit may alert the deviceor the user upon misplacement and/or eliminate or reduce radiating EMpower so as to avoid interferences.

Optionally, the placement unit may be designed to receive historicalpositioning data that is used as a reference point during the placementand/or replacement process. The historical positioning data may bereceived via a wireless and/or a wired connection with a similarmonitoring apparatus which is replaced by the monitoring apparatushousing the placement unit and/or from a information originating fromthe replaced monitoring apparatus which has been saved in the patientmanagement unit or elsewhere and/or from the position bank 472 which isdepicted in FIG. 6B. In such a manner, historical positioning data maybe generated by the similar and/or housing monitoring apparatus beforethe replacement and forwarded to the placement unit to allow the placingand/or the replacing of the monitoring apparatus as described above.

Reference is now made to FIGS. 7 and 8, which are schematicillustrations of a wearable monitoring apparatus 100 with a plurality oftransducers for beaming and/or capturing EM waves, according to someembodiments of the present invention. FIG. 7 depicts a wearablemonitoring apparatus 100 with an array of transducers 401 that isdesigned for transmitting EM signals capturing its reflections from aplurality of different directions. FIG. 8 depicts a wearable monitoringapparatus 100 with an array of transducers 401 that includes separatetransducers for capturing reflections from the tissues 405 and separatetransducers for transmitting EM waves toward the tissues 406. Thedifferent elements may be located in proximity to one another or spreadover different locations, in a similar manner the elements can have thesame pointing direction or can have different pointing directions. Forexample, one antenna element may be placed on the back of the user,another on the side and third on the front of the user thorax. In thegroup of antenna elements which are depicted in FIGS. 7 and 8 therelative phases of the respective signals feeding the antenna elementsare varied in such a manner that the effective radiation power of thephased-array is reinforced in a specific internal area of the user'sbody, for example in the pulmonary tissues of the user 101, andoptionally suppressed in other directions. In an equivalent manner, thephases of the received signals from the different antenna elements maybe combined to focus the elements on a specific internal location. Asdescribed above, reflections from the pulmonary tissue may be calibratedaccording to the reflections from reference tissues, for exampleincreasing the received reflected power from the muscle-to-lunginterface, by increasing the inflate-deflate differential signal on thelung gating. Any or all of the transmission and/or reception of the EMsignals can be adjusted jointly or separately to maximize the describedlung reflection.

By using multiple transducers the time/space separation may be improved.For example, different antenna elements are designed to be focused onreception and/or transmission in different directions, where theinterception of the transmission and reception areas of focus arestrongly emphasized respective to other areas, so as to improveisolation from internal weaker signals from strong reflection which mayor may not overlap in time.

Optionally, the array of transducers 401 comprises transmitting andintercepting antenna elements. By separating between transmitting andintercepting antenna elements, transmission and reception isolation isincreased. The improved isolation increases sensitivity to weakerreflections from inner tissues and/or organs, by reducing thereflections received from layers which are in proximity to thetransmitting antenna elements. Reception of strong reflections from thefirst layers in proximity to the transmitting antenna elements, such asskin and fat, are reduced or eliminated in separated receiving antennaelements, therefore achieving improved sensitivity to weaker signalsfrom deeper layers.

The separation of different reflection according to reflected areasallows overcoming microwave monitoring difficulties. For example, whentwo or more reflections from different areas are simultaneously, orsubstantially simultaneously, but overlap in time of reception,physiological phenomenon may be masked for example due to mutualcancellation. Focusing the reception and/or transmission to differentareas may isolate the two or more reflections from each other and enableefficient extraction of the physiological phenomenon. Optionally,multiple antenna elements and/or multiple transducers are used to reduceirregularities, such as noises, disturbances and/or interferences, whichare intercepted in part of the antenna element and/or transducers. Suchirregularities may be an outcome of power source instability,noise-figure changes, and changes in the attenuation of theelectromagnetic waves which are caused by fluctuations in the gapbetween the antenna and the skin. Using multi antenna elements and/ormulti transducers allows identifying and/or reducing and/or factoringout noises and disturbances. By separately tracking reflections fromdifferent sub areas of the monitored tissue and/or organ, noises anddisturbances may be separated, for example by detecting similarirregularities in reflections from different tissues.

In such cases array of transducers 401 may separate the reflection.

The wearable monitoring apparatus 100 may direct some or all of thetransducers to capture reflection from a certain tissue or split it overseparate tissues or connective tissues.

In some embodiments of the present invention, the wearable monitoringapparatus 100 implements one or more gating techniques for gating thereflected EM waves, for example as described in the co filed patentapplication. Such gating techniques allow synchronizing the monitoringwith cyclic physiological processes, such as the breathing cycle and thepace of the heart beats. As described in the co filed patentapplication, the time gating techniques may be used for focusing onreflections from the pulmonary tissue. However, time gating may notseparate reflections if the reflections are adjacent to one another onthe time axis. Optionally, the spatial separation is improved by beamingthe microwave from one transducer and capturing the reflections fromanother transducer. Optionally, the wearable monitoring apparatus, forexample as described in FIGS. 7 and 8, beams EM waves from one of theantenna elements 401 and captures the reflections thereof from one ormore other antenna elements. Optionally, the beamed EM waves aredirected to form a phased-array antenna with directivity pointing withsome angle to the desired reflection 405. In such a manner, thebackscattering radiation is scattered in an angle which is relativelywide, for example in relation to the backscattering radiation that isbeamed and captured by the same transducer. Optionally, where beams ofthe transmitting and intercepting transducers do not overlap,reflections resulting from tissue transitions are received off-beam andattenuated. In such a manner, the reflections from the borders of thetissue are not attenuated and the desired reflections are kept in thereoriginal intensity.

Optionally, one or more intercepting transducers are focused on thereference tissue while other intercepting transducers are focused on thedesired pulmonary tissue. Optionally, two or more different interceptingtransducers are focused on one or more reflection points.

As described above, the reflected EM waves may be gated during and/orbefore the analysis process. Using multiple transmitters, as depicted inFIGS. 7 and 8, may be used for increasing the separation betweendifferent reflections which are intercepted by the wearable monitoringapparatus. Optionally, the beams a microwave is a CW, as describedabove. Optionally, the CW is a chirp in which the frequency increases ordecreases with time. In such an embodiment, multiple-antenna-elementsmay be used to transmit and receive the CWs and still have focusingcapabilities. For example, one radiating transducer may distribute itsradiation across a wide area while the reception is phased by severaltransducers. In another example, a phased-array forms several beamswhich are directed to different locations. Optionally, some or more ofthe transducers includes phase shifters which are designed to point tothe desired location. The positioning of a phase-shifter may be adjustedaccording to the requirements of the reference chest model. Optionally,the phase-shifter is dynamically adjusted according to the analysis ofthe received reflections. For example, the phase-shifter may be directedto intercept a fat-to-muscle reflection by identifying a strong pass andan opposite-signed reflection from muscle-to-lung.

Optionally, phase-shifters are used for maximizing the amplitude of thewaveform of the received reflections. The waveform variance may beaffected by the breathing cycle and/or by the dielectric changes of thepulmonary tissue. For example, the phase-shifters are used formaximizing the amplitude of periodic signals such as the signal thatreflects the breathing process or the heart beating process.

The intensification of the waveform variance may be used for emphasizingin the small changes in the dielectric coefficients of the pulmonarytissue and for focusing the beam on the pulmonary tissue and/or on lungstransitions. Maximizing the waveform variance resulting from breathingcycles may be measured by correlating between the received reflectionsand separate measurements of the monitored user breathing.

In some embodiments of the present invention, the wearable monitoringapparatus 100 is adjusted according to the physical and anatomicalcondition and/or medical history of the monitored user. Optionally, theconfiguration is performed, either automatically and/or manually, afterthe wearable monitoring apparatus 100 is attached to user's body.Optionally, a configuration process is associated with the initialplacement of the wearable monitoring apparatus 100. The automaticconfiguration may be based on measurements which are preformed in realtime. Optionally a semi-manual configuration process is used where theuser and/or the treating caretaker are required to enter medical dataand/or to select a monitoring pattern and\or define various thresholdsfor notifications of either the medical treating team and/or the user.Optionally, the area of the receiving and/or transmitting element may beadapted to the physiology of the user. If the user has relatively thicklayers of fat, larger antenna element or elements may be used in orderto increase the sensitivity and the effective monitoring range.Optionally, the transducer may be defined to transmit more energy inorder to improve the sensitivity of the wearable monitoring apparatus.

Reference is now made, once again, to FIG. 2. In some embodiments of thepresent invention, a management node, such as the medical data center155 and/or the patient management unit allows the production ofstatistical reports, such as financial and/or usage related reports. Insuch an embodiment the data about the risks and/or the medical conditionof the users may be combined with billing and/or accounting data whichis related to the user. The medical data center 155 may contain usageand/or statistics data that may be accessed by administrative systemusers for billing, auditing and the like. For example, a medicalinsurance company may use usage statistics to ensure that user complywith medical treatment instructions they receive and/or with arequirement to wear the wearable monitoring apparatus 100.

Optionally, the system 150 may be integrated with a medical data system,such as a radiology information system (RIS), an electronic medicalrecord (EMR), and/or a personal health record (PHR). In such anembodiment, the system 150 may streaming the aforementioned data aboutthe monitored users to the medical data system. Optionally, theintegration may support records, in standards such as health level 7(HL7), general electric (GE) EMR format, EPIC EMR format, and Google™health format. In such an embodiment, data which is related to theplacement of the wearable monitoring apparatus and/or any other wearablebiological probe may be used for updating insurance rate and/or in amanner that improves patient compliance rates.

Optionally, the system 150 may include a device identification modulewhich is configured for Identifying a match between the outputs of acertain wearable monitoring apparatus 100 and the monitored user thatwears it. Such identification may be used for preventing from outputs ofa device that is worn by a first user to be associated with recordswhich related to a second user. For example, the wearable monitoringapparatus 100 may identify the user using characteristics of themeasured signal unique to him. In the case of a mismatch the system willalert.

Optionally, the system 150 may include a device authorization andactivation module which is configured for identifying and authenticatinga device before it is allowed to be connected to the system and/oractivated and/or enabled for activation. Authentication can be based onunique information stored in the wearable monitoring apparatus 100,Authentication information may be valid for a limited duration and/ornumber of activations. Such a module reduces fraud where a non-originalwearable monitoring apparatus is used within the system.

It is expected that during the life of a patent maturing from thisapplication many relevant methods and systems will be developed and thescope of the term a microwave, a transmitter, a receiver, and/or adevice are intended to include all such new technologies a priori.

As used herein the term “about” refers to ±10%.

The terms “comprises”, “comprising”, “includes”, “including”, “having”and their conjugates mean “including but not limited to”.

The term “consisting of means “including and limited to”.

The term “consisting essentially of” means that the composition, methodor structure may include additional ingredients, steps and/or parts, butonly if the additional ingredients, steps and/or parts do not materiallyalter the basic and novel characteristics of the claimed composition,method or structure.

As used herein, the singular form “a”, “an” and “the” include pluralreferences unless the context clearly dictates otherwise. For example,the term “a compound” or “at least one compound” may include a pluralityof compounds, including mixtures thereof.

Throughout this application, various embodiments of this invention maybe presented in a range format. It should be understood that thedescription in range format is merely for convenience and brevity andshould not be construed as an inflexible limitation on the scope of theinvention. Accordingly, the description of a range should be consideredto have specifically disclosed all the possible subranges as well asindividual numerical values within that range. For example, descriptionof a range such as from 1 to 6 should be considered to have specificallydisclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numberswithin that range, for example, 1, 2, 3, 4, 5, and 6. This appliesregardless of the breadth of the range.

Whenever a numerical range is indicated herein, it is meant to includeany cited numeral (fractional or integral) within the indicated range.The phrases “ranging/ranges between” a first indicate number and asecond indicate number and “ranging/ranges from” a first indicate number“to” a second indicate number are used herein interchangeably and aremeant to include the first and second indicated numbers and all thefractional and integral numerals therebetween.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination or as suitable in any other describedembodiment of the invention. Certain features described in the contextof various embodiments are not to be considered essential features ofthose embodiments, unless the embodiment is inoperative without thoseelements.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims.

All publications, patents and patent applications mentioned in thisspecification are herein incorporated in their entirety by referenceinto the specification, to the same extent as if each individualpublication, patent or patent application was specifically andindividually indicated to be incorporated herein by reference. Inaddition, citation or identification of any reference in thisapplication shall not be construed as an admission that such referenceis available as prior art to the present invention. To the extent thatsection headings are used, they should not be construed as necessarilylimiting.

1. A wearable monitoring apparatus for monitoring at least onebiological parameter of an internal tissue of an ambulatory user,comprising: at least one transducer having at least one antennaconfigured for at least one of delivering electromagnetic (EM) radiationto the internal tissue and intercepting said EM radiation from saidinternal tissue in a plurality of transmission sessions during a periodof at least 24 hours; a processing unit configured for analyzing saidintercepted EM radiation and identifying a change in the at least onebiological parameter accordingly; and a reporting unit configured forgenerating a report according to said change; wherein said at least oneantenna is configured for being disposed on the body of the ambulatoryuser.
 2. The wearable monitoring apparatus of claim 1, wherein saidprocessing unit comprises a communication module for communicating witha remote processing unit thereby allowing performing of at least one ofsaid analyzing and said identifying by said remote processing unit. 3.The wearable monitoring apparatus of claim 1, wherein said processingunit is configured for identifying said change by detecting at least oneof a trend, a biological process, and a pattern according to saidintercepted EM radiation of said plurality of transmission sessions. 4.The wearable monitoring apparatus of claim 1, wherein said processingunit is configured for evaluating a property change in a dielectricrelated property of the internal tissue in at least one of saidplurality of transmission sessions and performing said identificationaccording to said property change.
 5. The wearable monitoring apparatusof claim 1, wherein said plurality of transmission sessions areperformed in an adaptive rate.
 6. The wearable monitoring apparatus ofclaim 5, wherein said adaptive rate is determined according to aclinical state of the user, said processing unit being configured forcalculating said clinical state according to at least one output of anon EM radiation sensor and said intercepted EM radiation.
 7. Thewearable monitoring apparatus of claim 5, further comprising a posturedetection unit configured for detecting a posture of the user, saidadaptive rate being determined according to said posture.
 8. Thewearable monitoring apparatus of claim 1, wherein said reporting unit isconfigured for generating said report in real time.
 9. (canceled) 10.The wearable monitoring apparatus of claim 1, wherein said change isindicative of a fluid content change in the internal tissue during saidperiod.
 11. The wearable monitoring apparatus of claim 1, wherein saidchange is indicative of a member of a group consisting of: a trauma adegenerative process, atelectasis, a post-operative atelectasis, anacute respiratory deficiency syndrome (ARDS), an infectious cause, aninhaled toxins, a circulating exogenous toxins, a vasoactive substance,a disseminated intravascular coagulopathy (DIC), a burn, an emphysema, aimmunologic processes reaction, a uremia, a post drowning lung waterlevel, a pulmonary venous thrombosis, a stenosis, a veno-occlusivedisease, a hypoalbuminemia, a lymphatic insufficiency, a high altitudepulmonary edema (HAPE), a neurogenic pulmonary edema, a drug overdose, apulmonary embolism, an eclampsia, a postcardioversion, a postanesthetic,a postextubation, and a post-cardiopulmonary bypass an inflammationprogress of ARDS users, postoperative atelectasis.
 12. (canceled) 13.The wearable monitoring apparatus of claim 1, further comprising arepository configured for storing information pertaining to said user,said processing unit being configured for performing said analyzing withrespect to said information, wherein said information comprises at leastone of physiological, anatomical, and clinical data related to saiduser.
 14. The wearable monitoring apparatus of claim 1, furthercomprising a non EM radiation sensor configured for evaluating anindicator of the physical condition of said user, said processing unitidentifying said change by a combination of said indicator and saidintercepted EM radiation.
 15. (canceled)
 16. The wearable monitoringapparatus of claim 1, further comprising a non EM radiation sensorconfigured for evaluating an indicator to allow performing saidanalyzing with respect to said evaluated indicator, said non EMradiation sensor being a member of a group consisting of electromyogram(EMG), an ultrasound transducer, a blood pressure sensor, an opticalblood saturation detector, a pulse oximeter, electrocardiogram (ECG),tiltmeter and accelerometer an activity sensor, and a coagulometer. 17.The wearable monitoring apparatus of claim 1, further comprising a nonEM radiation sensor configured for detecting a pattern of aphysiological activity of the user, said processing unit beingconfigured for performing said analyzing with respect to said pattern.18. (canceled)
 19. The wearable monitoring apparatus of claim 1, whereinsaid processing unit is configured for detecting a pattern of aphysiological activity of the user, said processing unit beingconfigured for performing said analyzing with respect to said pattern.20. (canceled)
 21. The wearable monitoring apparatus of claim 1, whereinsaid processing unit is configured for detecting a physiologicalactivity of the user by analyzing said intercepted EM radiation, saidprocessing unit being configured for performing said identifying withrespect to said physiological activity.
 22. The wearable monitoringapparatus of claim 1, further comprising a posture detection unitconfigured for detecting a posture of the user, said processing unitbeing configured for analyzing said intercepted EM radiation withrespect to said posture.
 23. The wearable monitoring apparatus of claim1, wherein said change is indicative of a change in the concentration ofa solute in the internal tissue.
 24. The wearable monitoring apparatusof claim 23, wherein said solute is a member of a group consisting of asalt, glucose, and or inflammatory indicative fluid.
 25. (canceled) 26.The wearable monitoring apparatus of claim 1, wherein said EM radiationcomprises a narrowband signal of less than 50 Mega Hertz (MHz) bandwidthand a pulse signal of at least 0.5 gigahertz (GHz) bandwidth.
 27. Thewearable monitoring apparatus of claim 1, wherein said EM radiation istransmitted in at least one of a plurality of frequencies and a sweptfrequency mode.
 28. (canceled)
 29. The wearable monitoring apparatus ofclaim 1, further comprising a placement unit configured for providing aposition of said at least one antenna in relation to a referenceinternal tissue of the user, said delivering being performed withrespect to said position.
 30. (canceled)
 31. The wearable monitoringapparatus of claim 1, wherein said at least one antenna comprises aplanar wide band antenna.
 32. (canceled)
 33. The wearable monitoringapparatus of claim 1, wherein said at least one transducer, saidreporting unit, and said processing unit are configured to be integratedinto a garment.
 34. The wearable monitoring apparatus of claim 1,wherein said reporting unit is configured for providing treatmentinstructions. 35-36. (canceled)
 37. The wearable monitoring apparatus ofclaim 1, wherein said processing unit is configured for identifying saidchange using a tissue model adapted to said internal tissue.
 38. Thewearable monitoring apparatus of claim 1, wherein said at least onetransducer comprises a plurality of transducers configured fordelivering EM radiation to the internal tissue and intercepting saidintercepted EM radiation therefrom.
 39. The wearable monitoringapparatus of claim 38, wherein said plurality of transducers comprisesat least one transmitter configured for performing said delivering andat least one receiver configured for performing said intercepting. 40.The wearable monitoring apparatus of claim 38, wherein said at least onetransducer being configured for intercepting said intercepted EMradiation from a plurality of sub-areas of said internal tissue forimproving the resolution of said intercepted EM radiation.
 41. Thewearable monitoring apparatus of claim 40, wherein said processing unitis configured for reducing at least one of a noise, a disturbance, aposture movement effect and/or an interference intercepted by said atleast one first transducer by comparing segments of said intercepted EMradiation from said first and second sub-areas.
 42. A system formonitoring at least one biological parameter of an internal tissue of aplurality of ambulatory users, comprising: a plurality of wearabledevices, each configured for being disposed on the body of one of theplurality of ambulatory users and for identifying a change in the atleast one biological parameter according to electromagnetic (EM)radiation intercepted from an internal tissue of a respective of saidambulatory users in a plurality of transmission sessions during a periodof at least 24 hours; and a user management unit configured forreceiving said identified change from a respective said wearable deviceand generating a report accordingly. 43-69. (canceled)
 70. A widebandantenna, comprising: a printed metallic field transducer fortransmitting EM radiation; and an arrangement of at least one lumpedabsorbing element; wherein said arrangement having a minimal absorptionarea absorbing at least 75% of the energy absorbed by said arrangement;wherein a first distance is the smallest distance between a geometriccenter of said printed metallic field transducer and a perimeterencircling a transmission area of said printed metallic field transducerrequired for transmitting 50% of the energy of said EM radiation in thelowest end of a used frequency band with respect to infinite sizetransducer; wherein the distance of each point within said minimalabsorption area from said geometric center is at least said firstdistance.
 71. The wearable monitoring apparatus of claim 1, wherein saidprocessing unit is configured for being disposed on the body of theambulatory user.
 72. The wearable monitoring apparatus of claim 1,further comprising an attachment unit which detachably attaches themonitoring apparatus to said user in a specific position.
 73. Thewearable monitoring apparatus of claim 1, further comprising a placementunit which computes a misplacement of said at least one antenna inrelation to an internal tissue of said ambulatory user and outputting anotification about said misplacement.
 74. A method for monitoring atleast one biological parameter of an internal tissue of an ambulatoryuser, comprising: disposing a transducer on the body of the ambulatoryuser; delivering electromagnetic (EM) radiation to the internal tissue;intercepting said EM radiation from said internal tissue in a pluralityof transmission sessions during a period of at least 24 hours; analyzingsaid EM radiation and identifying a change in the at least onebiological parameter accordingly; and generating a report according tosaid change.
 75. The wearable monitoring apparatus of claim 1, whereinat least one of said processing unit and said reporting unit beingdisposed on the body of the ambulatory user.
 76. The wearable monitoringapparatus of claim 1, wherein said plurality of transmission sessionsare intermittent.
 77. The wearable monitoring apparatus of claim 1,wherein during said period, said processing unit is configured forperforming at least one of the following: computing a reduction to atleast one movement effect, and generating guidance instructions for atleast one of repositioning the wearable monitoring apparatus and guidingthe monitored user to a posture.
 78. The wearable monitoring apparatusof claim 1, wherein during said period, said processing unit isconfigured for performing at least one of the following: detecting atleast one of a misplacement and disengagement of the wearable monitoringapparatus, identifying a period suitable for performing a dataacquisition session, and identifying said change by at least one ofcalculating a baseline and identifying a normal range which are adjustedaccording to the monitored user
 79. The wearable monitoring apparatus ofclaim 1, wherein said processing comprises reducing the effect of amovement on said change identification, said movement comprises a memberof a group consisting of: a thoracic movement, an internal physiologicalactivity, and an external physiological activity irregularity.
 80. Thewearable monitoring apparatus of claim 1, wherein said processingcomprises reducing the effect of a movement on said changeidentification, said movement comprises a member of a group consistingof: an organ movement, an antenna movement, a change of posturemovement, a bodily movement, an activity related movement.
 81. Thewearable monitoring apparatus of claim 1, said processing unit isconfigured for performing said identifying according to an analysis ofdifferential physiological activities signals.
 82. The wearablemonitoring apparatus of claim 10, wherein said processing unit isconfigured for detecting a pattern of at least one physiologicalactivity of the user, said processing unit being configured forcalculating a clinical state of said user with respect to said fluidcontent change and to said pattern; wherein said at least oneintercepted EM radiation is being changed as an outcome of at least onethoracic movement during said period.
 83. The wearable monitoringapparatus of claim 29, wherein said placement unit performs at least oneof: monitoring and guiding the positioning of said wearable monitoringapparatus, monitoring and guiding the repositioning of said wearablemonitoring apparatus, and identifying at least one of a misplacement anda disengagement of said wearable monitoring apparatus.
 84. The wearablemonitoring apparatus of claim 29, wherein said placement unit controls amechanical adjustment unit which changes the positioning of saidwearable monitoring apparatus.